Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1781-2023
• Recall Event ID: 92328
• PMA Number: P010031S674
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP600555S, RTP601566S, RTP601569S, RTP602731S, RTP602733S, RTP601785S, RTP601786S, RTP601825S, RTP601826S, RTP601620S, RTP602203S, RTP602327S, RTP600744S, RTP600745S, RTP600762S, RTP601117S, RTP601187S, RTP601231S, RTP601906S, RTP603519S, RTP600475S, RTP600228S, RTP600308S, RTP600757S, RTP601116S, RTP601219S, RTP601221S, RTP601723S, RTP601724S, RTP601907S, RTP602117S, RTP602216S, RTP601572S, RTP602154S, RTP602038S, RTP600454S, RTP600670S, RTP601041S, RTP601066S, RTP601209S, RTP601801S, RTP600394S, RTP600397S, RTP600184S, RTP601049S, RTP601072S, RTP601822S, RTP600645S, RTP603289S, RTP603604S, RTP600559S, RTP600796S, RTP601834S, RTP600396S, RTP600738S, RTP600739S, RTP600740S, RTP600741S, RTP601589S, RTP601591S, RTP601595S, RTP601596S, RTP600148S, RTP600700S, RTP600627S, RTP601567S, RTP601186S, RTP601999S, RTP600819S, RTP601857S, RTP600576S, RTP600585S, RTP600779S, RTP600829S, RTP600452S, RTP601850S, RTP602030S, RTP602285S, RTP603440S, RTP600773S, RTP600498S, RTP600970S, RTP602267S, RTP602292S, RTP601227S, RTP600896S, RTP601034S, RTP601035S, RTP602213S, RTP602271S, RTP600671S, RTP600675S, RTP601862S, RTP600509S, RTP601568S, RTP600177S, RTP600093S, RTP600190S, RTP600191S, RTP600192S, RTP600660S, RTP600662S, RTP600663S, RTP600778S, RTP600806S, RTP600917S, RTP601179S, RTP601706S, RTP601707S, RTP601788S, RTP601793S, RTP602028S, RTP602611S, RTP600303S, RTP600647S, RTP600955S, RTP601988S, RTP602217S, RTP602283S, RTP602410S, RTP602413S, RTP601727S, RTP600904S, RTP600914S, RTP600915S, RTP600628S, RTP601232S, RTP602486S, RTP600181S, RTP600689S, RTP601081S, RTP601872S, RTP601982S, RTP602246S, RTP602403S, RTP602429S, RTP602439S, RTP603446S, RTP601830S, RTP601836S, RTP602088S, RTP602105S, RTP602124S, RTP603381S, RTP600701S, RTP601879S, RTP602405S, RTP600283S, RTP600284S, RTP600430S, RTP600634S, RTP600766S, RTP600816S, RTP600854S, RTP601884S, RTP602166S, RTP602168S, RTP602227S, RTP602269S, RTP602398S, RTP600930S, RTP601097S, RTP601159S, RTP601881S, RTP602081S, RTP602226S, RTP602427S, RTP602518S, RTP602605S, RTP600924S, RTP602063S, RTP600649S, RTP601625S, RTP601672S, RTP601831S, RTP601858S, RTP601936S, RTP601950S, RTP602234S, RTP602289S, RTP600835S, RTP602167S, RTP602356S, RTP600797S, RTP600110S, RTP600196S, RTP600227S, RTP600426S, RTP600434S, RTP601835S, RTP600286S, RTP600624S, RTP600653S, RTP601780S, RTP602017S, RTP602067S, RTP602378S, RTP602404S, RTP600439S, RTP600468S, RTP600676S, RTP602589S, RTP602596S, RTP600271S, RTP600921S, RTP600944S, RTP601206S, RTP601578S, RTP600614S, RTP601043S, RTP601105S, RTP602338S, RTP600219S, RTP600372S, RTP601554S, RTP600304S, RTP600269S, RTP600985S, RTP601604S, RTP601660S, RTP601791S, RTP602137S, RTP602499S, RTP602574S, RTP602636S, RTP602472S, RTP602542S, RTP602454S, RTP600805S, RTP602538S, RTP600443S, RTP603471S, RTP603472S, RTP603473S, RTP603474S, RTP603475S, RTP600209S, RTP600225S, RTP600247S, RTP600487S, RTP600515S, RTP600522S, RTP600563S, RTP600682S, RTP600929S, RTP600988S, RTP602099S, RTP602225S, RTP602342S, RTP602401S, RTP602469S, RTP602501S, RTP602502S, RTP602537S, RTP602541S, RTP602576S, RTP602588S, RTP602598S, RTP600224S, RTP602256S, RTP602568S, RTP603659S, RTP601981S, RTP602437S, RTP601195S, RTP601745S, RTP602266S, RTP602281S, RTP600472S, RTP600592S, RTP601028S, RTP601076S, RTP601752S, RTP601759S, RTP601761S, RTP601762S, RTP601874S, RTP601886S, RTP601921S, RTP600496S, RTP600830S, RTP600966S, RTP600967S, RTP601683S, RTP601760S, RTP602060S, RTP602270S, RTP602302S, RTP602286S, RTP601942S, RTP601114S, RTP602340S, RTP600077S, RTP600410S, RTP602597S, RTP600399S, RTP600467S, RTP601042S, RTP601141S, RTP601061S, RTP600753S, RTP600808S, RTP600648S, RTP600395S, RTP602389S, RTP602400S, RTP602584S, RTP600497S, RTP600331S, RTP601560S, RTP601877S, RTP600462S, RTP600504S, RTP600622S, RTP601708S, RTP602163S, RTP602164S, RTP601812S, RTP602515S, RTP600597S, RTP601217S, RTP601222S, RTP601223S, RTP601224S, RTP601693S, RTP601900S, RTP602162S, RTP602195S, RTP602335S, RTP600231S, RTP600313S, RTP601851S, RTP602125S, RTP602264S, RTP602276S, RTP602434S, RTP602435S, RTP600161S, RTP602051S, RTP600297S, RTP600418S, RTP600822S, RTP601244S, RTP601245S, RTP601546S, RTP601711S, RTP601821S, RTP602442S, RTP602455S, RTP602609S, RTP603498S, RTP600694S, RTP600707S, RTP601003S, RTP601571S, RTP602072S, RTP602094S, RTP602337S, RTP602341S, RTP602375S, RTP602581S, RTP603510S, RTP600193S, RTP600457S, RTP601080S, RTP601103S, RTP601121S, RTP601632S, RTP601636S, RTP601924S, RTP601946S, RTP602395S, RTP602396S, RTP601612S, RTP601689S, RTP600330S, RTP600882S, RTP600884S, RTP602100S, RTP600069S, RTP600710S, RTP600769S, RTP600815S, RTP601147S, RTP601920S, RTP602229S, RTP602363S, RTP602409S, RTP602509S, RTP602606S, RTP601057S, RTP601882S, RTP600366S, RTP600534S, RTP601814S, RTP600258S, RTP600948S, RTP601065S, RTP601083S, RTP602077S, RTP602466S, RTP602503S, RTP602525S, RTP602534S, RTP602556S, RTP602557S, RTP602595S, RTP603048S, RTP603204S, RTP603326S, RTP603327S, RTP600277S, RTP600356S, RTP600928S, RTP601655S, RTP601769S, RTP601770S, RTP601773S, RTP600263S, RTP601777S, RTP601795S, RTP602535S, RTP600361S, RTP600433S, RTP600931S, RTP600428S, RTP600898S, RTP600800S, RTP600249S, RTP600903S, RTP600916S, RTP601811S, RTP601971S, RTP603606S, RTP600242S, RTP600768S, RTP600890S, RTP600891S, RTP600305S, RTP600865S, RTP602228S, RTP600275S, RTP601019S, RTP601182S, RTP602352S, RTP600280S, RTP601848S, RTP600281S, RTP600937S, RTP602037S, RTP600442S, RTP600456S, RTP600899S, RTP600969S, RTP601721S, RTP601725S, RTP601764S, RTP601765S, RTP601940S, RTP602159S, RTP602160S, RTP600721S, RTP600791S, RTP600841S, RTP600703S, RTP600783S, RTP602083S, RTP602393S, RTP601688S, RTP601951S, RTP601972S, RTP602599S, RTP600802S, RTP601931S, RTP602459S, RTP602554S, RTP603516S, RTP603518S, RTP600602S, RTP600749S, RTP600760S, RTP601630S, RTP601641S, RTP601642S, RTP601790S, RTP602065S, RTP602199S, RTP602421S, RTP601210S, RTP600619S, RTP600982S, RTP601990S, RTP602024S, RTP601960S, RTP602021S, RTP602170S, RTP602172S, RTP600850S, RTP602022S, RTP602479S, RTP600147S, RTP600737S, RTP600764S, RTP600956S, RTP601650S, RTP601870S, RTP601905S, RTP601918S, RTP601938S, RTP600259S, RTP601583S, RTP601947S, RTP600229S, RTP600440S, RTP601202S, RTP601555S, RTP601731S, RTP600213S, RTP601196S, RTP601738S, RTP601966S, RTP600894S, RTP601052S, RTP601134S, RTP601233S, RTP601732S, RTP602309S, RTP602326S, RTP602577S, RTP602477S, RTP602478S, RTP600517S, RTP600519S, RTP601144S, RTP601666S, RTP601730S, RTP601875S, RTP602006S, RTP600127S, RTP600142S, RTP600495S, RTP600533S, RTP600590S, RTP600838S, RTP600973S, RTP600974S, RTP601611S, RTP601618S, RTP601722S, RTP601749S, RTP601970S, RTP602066S, RTP602073S, RTP602220S, RTP602300S, RTP602353S, RTP602387S, RTP602316S, RTP600491S, RTP600831S, RTP601670S, RTP600827S, RTP603608S, RTP603477S, RTP600605S, RTP600872S, RTP601128S, RTP601194S, RTP600174S, RTP600537S, RTP600089S, RTP600125S, RTP600999S, RTP600223S, RTP601216S, RTP601894S, RTP601911S, RTP602012S, RTP602048S, RTP602138S, RTP602559S, RTP600122S, RTP600167S, RTP600168S, RTP600171S, RTP600173S, RTP600321S, RTP600389S, RTP600419S, RTP600546S, RTP600652S, RTP600687S, RTP600777S, RTP601017S, RTP601685S, RTP601783S, RTP602206S, RTP602236S, RTP602304S, RTP602513S, RTP601570S, RTP601648S, RTP601781S, RTP600166S, RTP600218S, RTP600923S, RTP602010S, RTP600488S, RTP601007S, RTP602148S, RTP600118S, RTP600983S, RTP601102S, RTP601109S, RTP601813S, RTP601929S, RTP601890S, RTP601973S, RTP602496S, RTP600513S, RTP602089S, RTP602374S, RTP602284S, RTP602041S, RTP602323S, RTP600232S, RTP600503S, RTP600594S, RTP600692S, RTP600709S, RTP600939S, RTP600962S, RTP600991S, RTP602151S, RTP602358S, RTP600659S, RTP600933S, RTP601145S, RTP601691S, RTP601692S, RTP601694S, RTP602178S, RTP600889S, RTP602587S, RTP600935S, RTP601787S, RTP602095S, RTP602243S, RTP600811S, RTP601729S, RTP601599S, RTP601895S, RTP602255S, RTP602369S, RTP602443S, RTP602444S, RTP602475S, RTP602624S, RTP602625S, RTP602626S, RTP603450S, RTP603451S, RTP603452S, RTP603483S, RTP603542S, RTP601036S, RTP600541S, RTP600905S, RTP601633S, RTP602061S, RTP600636S, RTP600728S, RTP601550S, RTP600552S, RTP600256S, RTP600460S, RTP601123S, RTP602026S, RTP602123S, RTP602222S, RTP602360S, RTP600116S, RTP600523S, RTP600866S, RTP600906S, RTP600907S, RTP601876S, RTP601916S, RTP602107S, RTP602351S, RTP600270S, RTP600821S, RTP600843S, RTP601945S, RTP600927S, RTP600216S, RTP600246S, RTP600383S, RTP600461S, RTP600528S, RTP600584S, RTP600677S, RTP600702S, RTP600814S, RTP600818S, RTP600824S, RTP600867S, RTP600947S, RTP601020S, RTP601054S, RTP601082S, RTP601656S, RTP601717S, RTP602252S, RTP603569S, RTP601958S, RTP601013S, RTP600506S, RTP600536S, RTP601757S, RTP601977S, RTP600480S, RTP600846S, RTP601843S, RTP602402S, RTP601146S, RTP600320S, RTP600451S, RTP600716S, RTP601867S, RTP600087S, RTP600674S, RTP600803S, RTP601709S, RTP601845S, RTP601151S, RTP601996S, RTP600151S, RTP600421S, RTP600450S, RTP600540S, RTP601181S, RTP601844S, RTP602086S, RTP602489S, RTP601070S, RTP600144S, RTP600427S, RTP600485S, RTP600610S, RTP600807S, RTP600836S, RTP601748S, RTP601859S, RTP602282S, RTP602451S, RTP602452S, RTP602563S, RTP602632S, RTP603432S, RTP603397S, RTP600885S, RTP601902S, RTP601673S, RTP601674S, RTP601675S, RTP601926S, RTP601927S, RTP601928S, RTP601239S, RTP602250S, RTP600317S, RTP600319S, RTP600413S, RTP600422S, RTP600424S, RTP601016S, RTP601199S, RTP601726S, RTP601789S, RTP601868S, RTP601955S, RTP602074S, RTP602153S, RTP602194S, RTP602218S, RTP602287S, RTP602290S, RTP602303S, RTP602330S, RTP602357S, RTP602390S, RTP602562S, RTP603681S, RTP603685S, RTP603683S, RTP600240S, RTP602558S, RTP601933S, RTP602280S, RTP602604S, RTP601897S, RTP602569S, RTP600200S, RTP600593S, RTP602011S, RTP600198S, RTP600932S, RTP601119S, RTP601162S, RTP601185S, RTP601203S, RTP602169S, RTP602288S, RTP603571S, RTP603590S, RTP601954S, RTP600134S, RTP601073S, RTP603574S, RTP600074S, RTP600188S, RTP600631S, RTP600977S, RTP601750S, RTP600445S, RTP601582S, RTP602025S, RTP602371S, RTP601176S, RTP602056S, RTP600267S, RTP600285S, RTP602467S, RTP600111S, RTP600119S, RTP600431S, RTP600441S, RTP600879S, RTP602555S, RTP601663S, RTP601152S, RTP600566S, RTP603068S, RTP600170S, RTP600752S, RTP600873S, RTP601032S, RTP601150S, RTP601815S, RTP602106S, RTP602272S, RTP602399S, RTP602539S, RTP600543S, RTP601077S, RTP601637S, RTP601676S, RTP601714S, RTP601984S, RTP602040S, RTP602254S, RTP602520S, RTP603366S, RTP602047S, RTP601634S, RTP601619S, RTP601193S, RTP601617S, RTP601799S, RTP601006S, RTP602029S, RTP602600S, RTP602618S, RTP600912S, RTP601645S, RTP602540S, RTP602446S, RTP602494S, RTP602619S, RTP602637S, RTP601559S, RTP601734S, RTP602076S, RTP602504S, RTP602746S, RTP602113S, RTP600861S, RTP600314S, RTP600787S, RTP600945S, RTP603583S, RTP600711S, RTP600712S, RTP600826S, RTP601025S, RTP601101S, RTP601142S, RTP601242S, RTP601873S, RTP601967S, RTP602456S, RTP600567S, RTP603627S, RTP603628S, RTP603629S, RTP603631S, RTP600817S, RTP600856S, RTP600859S, RTP601069S, RTP601212S, RTP601606S, RTP601608S, RTP601665S, RTP601899S, RTP601908S, RTP602085S, RTP602253S, RTP602370S, RTP600641S, RTP600719S, RTP601992S, RTP602622S, RTP601980S, RTP603469S, RTP600790S, RTP600886S, RTP601556S, RTP602190S, RTP600470S, RTP600965S, RTP601125S, RTP602109S, RTP602355S, RTP600492S, RTP600971S, RTP601686S, RTP601744S, RTP602053S, RTP602055S, RTP602346S, RTP602366S, RTP602617S, RTP600079S, RTP600387S, RTP600940S, RTP600992S, RTP601614S, RTP600120S, RTP600621S, RTP600957S, RTP600961S, RTP600980S, RTP600989S, RTP600994S, RTP601005S, RTP601033S, RTP601056S, RTP601078S, RTP601178S, RTP601183S, RTP601218S, RTP601677S, RTP601768S, RTP601957S, RTP600448S, RTP600698S, RTP600823S, RTP601739S, RTP602230S, RTP600276S, RTP600477S, RTP601778S, RTP602043S, RTP602349S, RTP600862S, RTP600096S, RTP600690S, RTP600950S, RTP601058S, RTP601110S, RTP602362S, RTP600612S, RTP600644S, RTP602046S, RTP602096S, RTP602332S, RTP603444S, RTP602586S, RTP600106S, RTP600186S, RTP600253S, RTP600254S, RTP600309S, RTP600386S, RTP600388S, RTP600564S, RTP600578S, RTP600651S, RTP600839S, RTP600860S, RTP600918S, RTP601023S, RTP601092S, RTP602143S, RTP602237S, RTP602372S, RTP601659S, RTP602638S, RTP603521S, RTP603556S, RTP602376S, RTP602103S, RTP600136S, RTP600586S, RTP601029S, RTP601238S, RTP602233S, RTP601860S, RTP601704S, RTP600632S, RTP600301S, RTP602126S, RTP600547S, RTP600638S, RTP600908S, RTP601048S, RTP601154S, RTP601565S, RTP600581S, RTP601557S, RTP601584S, RTP601684S, RTP601912S, RTP600771S, RTP602027S, RTP600512S, RTP602453S, RTP601701S, RTP602204S, RTP601807S, RTP601810S, RTP602197S, RTP600398S, RTP601169S, RTP600679S, RTP600680S, RTP600681S, RTP600697S, RTP601009S, RTP601098S, RTP601668S, RTP601719S, RTP601733S, RTP602039S, RTP602320S, RTP602566S, RTP603479S, RTP603480S, RTP600273S, RTP602447S, RTP600133S, RTP600261S, RTP600463S, RTP600667S, RTP600772S, RTP600972S, RTP601093S, RTP601909S, RTP602146S, RTP600657S, RTP601197S, RTP601698S, RTP602129S, RTP600342S, RTP601132S, RTP602240S, RTP602097S, RTP601111S, RTP601653S, RTP600414S, RTP600415S, RTP601638S, RTP603658S, RTP601240S, RTP602321S, RTP600108S, RTP600244S, RTP600580S, RTP600750S, RTP600763S, RTP600987S, RTP601030S, RTP602491S, RTP602571S, RTP602608S, RTP602641S, RTP603454S, RTP603550S, RTP600109S, RTP600157S, RTP600234S, RTP600505S, RTP600545S, RTP602268S, RTP602493S, RTP602570S, RTP602616S, RTP602019S, RTP602210S, RTP602211S, RTP600589S, RTP600618S, RTP601002S, RTP601091S, RTP601099S, RTP602054S, RTP602361S, RTP600137S, RTP600494S, RTP600934S, RTP601976S, RTP600883S, RTP602215S, RTP602388S, RTP601243S, RTP601348S, RTP602334S, RTP603372S, RTP600195S, RTP600245S, RTP600524S, RTP600756S, RTP601064S, RTP601087S, RTP601601S, RTP602359S, RTP600295S, RTP600311S, RTP600623S, RTP600910S, RTP600946S, RTP601605S, RTP601703S, RTP601904S, RTP601923S, RTP601925S, RTP602308S, RTP602311S, RTP602377S, RTP602391S, RTP602461S, RTP602572S, RTP601192S, RTP602174S, RTP603497S, RSO609693S, RTP602101S, RTP602142S, RTP602221S, RTP602277S, RTP602296S, RTP602298S, RTP602301S, RTP602333S, RTP602381S, RTP602382S, RTP602383S, RTP602384S, RTP602430S, RTP602431S, RTP602433S, RTP602440S, RTP602445S, RTP602523S, RTP602700S, RTP602686S, RTP602718S, RTP602726S, RTP602734S, RTP602762S, RTP602763S, RTP602765S, RTP602767S, RTP602838S, RTP602839S, RTP602873S, RTP602876S, RTP602877S, RTP602897S, RTP602907S, RTP602908S, RTP602909S, RTP602917S, RTP603034S, RTP603035S, RTP603042S, RTP603043S, RTP603044S, RTP603045S, RTP603172S, RTP603188S, RTP603196S, RTP603202S, RTP603205S, RTP603207S, RTP603223S, RTP603225S, RTP603226S, RTP603227S, RTP603228S, RTP603229S, RTP603236S, RTP603240S, RTP603252S, RTP603253S, RTP603254S, RTP603255S, RTP603283S, RTP603321S, RTP603322S, RTP603325S, RTP603386S, RTP603387S, RTP603394S, RTP603395S, RTP603433S, RTP603434S, RTP603435S, RTP603436S, RTP603437S, RTP603438S, RTP603461S, RTP603470S, RTP603476S, RTP603714S, RTP600121S, RTP600250S, RTP600291S, RTP600293S, RTP600855S, RTP600863S, RTP600864S, RTP600881S, RTP601143S, RTP602070S, RTP602634S, RTP602635S, RTP602642S, RTP602643S, RTP602644S, RTP602645S, RTP602646S, RTP602647S, RTP602648S, RTP602649S, RTP602650S, RTP602651S, RTP602652S, RTP602653S, RTP602654S, RTP602655S, RTP602661S, RTP602662S, RTP602664S, RTP602666S, RTP602669S, RTP602670S, RTP602672S, RTP602682S, RTP602684S, RTP602685S, RTP602687S, RTP602690S, RTP602691S, RTP602692S, RTP602693S, RTP602694S, RTP602695S, RTP602696S, RTP602697S, RTP602699S, RTP602701S, RTP602702S, RTP602704S, RTP602705S, RTP602706S, RTP602707S, RTP602708S, RTP602709S, RTP602710S, RTP602712S, RTP602713S, RTP602714S, RTP602715S, RTP602716S, RTP602719S, RTP602721S, RTP602723S, RTP602724S, RTP602725S, RTP602727S, RTP602728S, RTP602729S, RTP602735S, RTP602736S, RTP602737S, RTP602738S, RTP602739S, RTP602740S, RTP602741S, RTP602742S, RTP602743S, RTP602745S, RTP602747S, RTP602748S, RTP602749S, RTP602750S, RTP602751S, RTP602753S, RTP602754S, RTP602755S, RTP602756S, RTP602757S, RTP602758S, RTP602759S, RTP602760S, RTP602761S, RTP602764S, RTP602772S, RTP602775S, RTP602776S, RTP602777S, RTP602778S, RTP602779S, RTP602780S, RTP602781S, RTP602782S, RTP602783S, RTP602784S, RTP602785S, RTP602786S, RTP602787S, RTP602788S, RTP602789S, RTP602790S, RTP602791S, RTP602794S, RTP602795S, RTP602796S, RTP602797S, RTP602798S, RTP602800S, RTP602801S, RTP602803S, RTP602804S, RTP602805S, RTP602806S, RTP602810S, RTP602811S, RTP602813S, RTP602814S, RTP602815S, RTP602816S, RTP602817S, RTP602818S, RTP602819S, RTP602820S, RTP602821S, RTP602822S, RTP602823S, RTP602824S, RTP602825S, RTP602827S, RTP602828S, RTP602829S, RTP602830S, RTP602831S, RTP602832S, RTP602835S, RTP602840S, RTP602841S, RTP602843S, RTP602844S, RTP602845S, RTP602846S, RTP602847S, RTP602848S, RTP602849S, RTP602850S, RTP602851S, RTP602852S, RTP602853S, RTP602854S, RTP602855S, RTP602856S, RTP602857S, RTP602858S, RTP602859S, RTP602860S, RTP602861S, RTP602862S, RTP602863S, RTP602864S, RTP602865S, RTP602866S, RTP602867S, RTP602868S, RTP602869S, RTP602870S, RTP602871S, RTP602872S, RTP602875S, RTP602878S, RTP602879S, RTP602880S, RTP602881S, RTP602882S, RTP602883S, RTP602884S, RTP602885S, RTP602886S, RTP602887S, RTP602888S, RTP602889S, RTP602890S, RTP602891S, RTP602892S, RTP602893S, RTP602894S, RTP602895S, RTP602901S, RTP602904S, RTP602906S, RTP602921S, RTP602922S, RTP602923S, RTP602924S, RTP602925S, RTP602926S, RTP602928S, RTP602929S, RTP602930S, RTP602931S, RTP602932S, RTP602934S, RTP602935S, RTP602936S, RTP602938S, RTP602940S, RTP602941S, RTP602942S, RTP602943S, RTP602944S, RTP602945S, RTP602946S, RTP602947S, RTP602949S, RTP602950S, RTP602951S, RTP602955S, RTP602957S, RTP602961S, RTP602962S, RTP602964S, RTP602966S, RTP602999S, RTP603001S, RTP603002S, RTP603003S, RTP603006S, RTP603007S, RTP603008S, RTP603009S, RTP603014S, RTP603018S, RTP603027S, RTP603031S, RTP603032S, RTP603049S, RTP603051S, RTP603054S, RTP603055S, RTP603056S, RTP603057S, RTP603061S, RTP603063S, RTP603064S, RTP603065S, RTP603066S, RTP603067S, RTP603071S, RTP603072S, RTP603073S, RTP603074S, RTP603075S, RTP603078S, RTP603079S, RTP603080S, RTP603081S, RTP603082S, RTP603090S, RTP603091S, RTP603093S, RTP603094S, RTP603098S, RTP603105S, RTP603113S, RTP603114S, RTP603115S, RTP603116S, RTP603117S, RTP603119S, RTP603120S, RTP603121S, RTP603134S, RTP603137S, RTP603140S, RTP603144S, RTP603146S, RTP603156S, RTP603158S, RTP603159S, RTP603160S, RTP603161S, RTP603164S, RTP603169S, RTP603170S, RTP603171S, RTP603173S, RTP603175S, RTP603176S, RTP603177S, RTP603179S, RTP603181S, RTP603182S, RTP603183S, RTP603185S, RTP603186S, RTP603187S, RTP603189S, RTP603198S, RTP603199S, RTP603201S, RTP603203S, RTP603206S, RTP603208S, RTP603212S, RTP603213S, RTP603214S, RTP603215S, RTP603216S, RTP603217S, RTP603218S, RTP603219S, RTP603220S, RTP603221S, RTP603231S, RTP603256S, RTP603257S, RTP603258S, RTP603259S, RTP603260S, RTP603261S, RTP603262S, RTP603264S, RTP603265S, RTP603266S, RTP603267S, RTP603268S, RTP603269S, RTP603270S, RTP603271S, RTP603272S, RTP603273S, RTP603274S, RTP603275S, RTP603276S, RTP603279S, RTP603281S, RTP603282S, RTP603284S, RTP603285S, RTP603287S, RTP603288S, RTP603290S, RTP603292S, RTP603293S, RTP603295S, RTP603297S, RTP603298S, RTP603300S, RTP603301S, RTP603302S, RTP603303S, RTP603304S, RTP603307S, RTP603308S, RTP603309S, RTP603311S, RTP603313S, RTP603314S, RTP603317S, RTP603318S, RTP603324S, RTP603328S, RTP603329S, RTP603330S, RTP603331S, RTP603332S, RTP603333S, RTP603334S, RTP603335S, RTP603336S, RTP603337S, RTP603338S, RTP603339S, RTP603340S, RTP603345S, RTP603346S, RTP603347S, RTP603348S, RTP603349S, RTP603351S, RTP603352S, RTP603359S, RTP603360S, RTP603361S, RTP603362S, RTP603363S, RTP603364S, RTP603367S, RTP603368S, RTP603369S, RTP603370S, RTP603371S, RTP603373S, RTP603375S, RTP603376S, RTP603377S, RTP603378S, RTP603379S, RTP603380S, RTP603383S, RTP603384S, RTP603385S, RTP603389S, RTP603390S, RTP603391S, RTP603392S, RTP603399S, RTP603400S, RTP603401S, RTP603402S, RTP603403S, RTP603404S, RTP603405S, RTP603406S, RTP603407S, RTP603408S, RTP603417S, RTP603419S, RTP603420S, RTP603421S, RTP603422S, RTP603423S, RTP603424S, RTP603425S, RTP603426S, RTP603427S, RTP603428S, RTP603429S, RTP603431S, RTP603439S, RTP603441S, RTP603442S, RTP603443S, RTP603445S, RTP603447S, RTP603448S, RTP603449S, RTP603453S, RTP603456S, RTP603457S, RTP603458S, RTP603460S, RTP603462S, RTP603463S, RTP603465S, RTP603466S, RTP603478S, RTP603501S, RTP603502S, RTP603503S, RTP603506S, RTP603507S, RTP603509S, RTP603511S, RTP603517S, RTP603520S, RTP603522S, RTP603523S, RTP603524S, RTP603527S, RTP603528S, RTP603530S, RTP603540S, RTP603545S, RTP603546S, RTP603551S, RTP603557S, RTP603562S, RTP603567S, RTP603568S, RTP603570S, RTP603572S, RTP603573S, RTP603575S, RTP603579S, RTP603582S, RTP603587S, RTP603588S, RTP603589S, RTP603593S, RTP603595S, RTP603613S, RTP603620S, RTP603637S, RTP603647S, RTP603651S, RTP603674S, RTP603672S, RTP603673S, RTP600465S, RTP600466S, RTP601887S, RTP601953S, RTP601561S, RTP602317S, RTP602052S, RTP600717S, RTP600986S, RTP601133S, RTP601989S, RTP600449S, RTP601615S, RTP602157S, RTP602158S, RTP602275S, RTP602591S, RTP603641S, RTP603700S, RTP601039S, RTP601702S, RTP600289S, RTP602307S, RTP601944S, RTP602044S, RTP600938S, RTP600535S, RTP600723S, RTP600725S, RTP600874S, RTP602149S, RTP600804S, RTP600620S, RTP600643S, RTP602614S, RTP600379S, RTP600607S, RTP601012S, RTP601014S, RTP601175S, RTP601959S, RTP600520S, RTP600733S, RTP600098S, RTP600775S, RTP600781S, RTP601553S, RTP601797S, RTP602238S, RTP600404S, RTP600408S, RTP600573S, RTP601038S, RTP601170S, RTP601623S, RTP601913S, RTP602090S, RTP600241S, RTP602373S, RTP600086S, RTP600126S, RTP600175S, RTP600964S, RTP601934S, RTP602108S, RTP602110S, RTP600481S, RTP600609S, RTP600693S, RTP600997S, RTP601180S, RTP601763S, RTP601965S, RTP602140S, RTP602436S, RTP603555S, RTP600255S, RTP601161S, RTP601241S, RTP601400S, RTP601664S, RTP601678S, RTP601679S, RTP602315S, RTP602087S, RTP602198S, RTP601160S, RTP601964S, RTP602514S, RTP602312S, RTP600076S, RTP600406S, RTP600412S, RTP600417S, RTP600606S, RTP600617S, RTP600642S, RTP600919S, RTP601088S, RTP601917S, RTP602049S, RTP602262S, RTP602560S, RTP600691S, RTP602621S, RTP600696S, RTP601230S, RTP600786S, RTP601621S, RTP601622S, RTP600608S, RTP600635S, RTP600743S, RTP601855S, RTP601157S, RTP601758S, RTP602033S, RTP600279S, RTP601680S, RTP601930S, RTP600128S, RTP600684S, RTP600685S, RTP600952S, RTP600959S, RTP600960S, RTP601573S, RTP601766S, RTP601796S, RTP601847S, RTP601883S, RTP602057S, RTP602104S, RTP602274S, RTP602367S, RTP602463S, RTP602482S, RTP602573S, RTP602575S, RTP602615S, RTP600162S, RTP600163S, RTP600164S, RTP600226S, RTP601059S, RTP601155S, RTP601574S, RTP602036S, RTP601609S, RTP601610S, RTP600149S, RTP600197S, RTP600211S, RTP600214S, RTP600478S, RTP600483S, RTP600639S, RTP600646S, RTP600785S, RTP601832S, RTP600661S, RTP600887S, RTP602368S, RTP603192S, RTP603193S, RTP603195S, RTP603010S, RTP603013S, RTP600724S, RTP601138S, RTP602241S, RTP602291S, RTP602009S, RTP602567S, RTP600469S, RTP600664S, RTP600678S, RTP601705S, RTP602062S, RTP600189S, RTP600208S, RTP600640S, RTP601190S, RTP601735S, RTP602261S, RTP600596S, RTP602318S, RTP602313S, RTP603320S, RTP603200S, RTP600482S, RTP600103S, RTP600654S, RTP600795S, RTP601024S, RTP602339S, RTP601639S, RTP600322S, RTP600510S, RTP601198S, RTP602294S, RTP600782S, RTP600572S, RTP602128S, RTP600637S, RTP600599S, RTP601027S, RTP600588S, RTP602354S, RTP601084S, RTP601085S, RTP600102S, RTP600158S, RTP600436S, RTP600437S, RTP601046S, RTP601172S, RTP601896S, RTP602578S, RTP602580S, RTP601640S, RTP601956S, RTP602079S, RTP602130S, RTP602131S, RTP602468S, RTP602593S, RTP602432S, RTP601063S, RTP601068S, RTP602032S, RTP602069S, RTP602118S, RTP602119S, RTP602184S, RTP600730S, RTP600748S, RTP600993S, RTP601095S, RTP601802S, RTP600562S, RTP601096S, RTP602235S, RTP601687S, RTP602092S, RTP602127S, RTP600409S, RTP600140S, RTP600403S, RTP601753S, RTP601816S, RTP602084S, RTP602141S, RTP600794S, RTP600793S, RTP600951S, RTP601008S, RTP601067S, RTP601135S, RTP602364S, RTP600666S, RTP600770S, RTP601234S, RTP602416S, RTP600591S, RTP600754S, RTP600792S, RTP600981S, RTP601107S, RTP601131S, RTP601547S, RTP601551S, RTP601647S, RTP601710S, RTP601716S, RTP601741S, RTP601772S, RTP601804S, RTP601235S, RTP601236S, RTP601657S, RTP601740S, RTP601806S, RTP601939S, RTP602161S, RTP600920S, RTP601108S, RTP601962S, RTP600774S, RTP602145S, RTP600668S, RTP600799S, RTP600922S, RTP601124S, RTP601136S, RTP601140S, RTP601837S, RTP601892S, RTP602212S, RTP602449S, RTP602450S, RTP602490S, RTP602511S, RTP600302S, RTP601948S, RTP600384S, RTP602565S, RTP603467S, RTP600542S, RTP600577S, RTP601166S, RTP602152S, RTP602305S, RTP602324S, RTP602564S, RTP600078S, RTP602415S, RTP600699S, RTP601794S, RTP602426S, RTP600570S, RTP601062S, RTP600215S, RTP600958S, RTP600160S, RTP602603S, RTP600877S, RTP600878S, RTP601643S, RTP601644S, RTP601986S, RTP601987S, RTP602257S, RTP600507S, RTP600892S, RTP600574S, RTP600820S, RTP601941S, RTP602188S, RTP602464S, RTP602492S, RTP602498S, RTP602505S, RTP602506S, RTP602507S, RTP602508S, RTP602744S, RTP602905S, RTP602910S, RTP602911S, RTP602912S, RTP602913S, RTP602914S, RTP602918S, RTP602919S, RTP602920S, RTP603484S, RTP603485S, RTP603486S, RTP603487S, RTP603488S, RTP603489S, RTP603491S, RTP603492S, RTP603493S, RTP603494S, RTP603496S, RTP600107S, RTP600112S, RTP600115S, RTP600165S, RTP600264S, RTP600405S, RTP600471S, RTP600568S, RTP600901S, RTP601225S, RTP601736S, RTP602064S, RTP602068S, RTP602139S, RTP602224S, RTP602422S, RTP602585S, RTP600172S, RTP600373S, RTP601037S, RTP601053S, RTP601552S, RTP601869S, RTP602185S, RTP600138S, RTP600390S, RTP602121S, RTP602176S, RTP600458S, RTP600569S, RTP600900S, RTP602071S, RTP602120S, RTP601624S, RTP601626S, RTP601743S, RTP602023S, RTP602144S, RTP600400S, RTP600727S, RTP601015S, RTP601086S, RTP601737S, RTP601779S, RTP601863S, RTP601866S, RTP602058S, RTP602189S, RTP602345S, RTP602457S, RTP602458S, RTP602471S, RTP602553S, RTP602613S, RTP602633S, RTP600205S, RTP601865S, RTP602407S, RTP600655S, RTP600658S, RTP602112S, RTP600484S, RTP600715S, RTP601021S, RTP601871S, RTP601649S, RTP601208S, RTP602350S, RTP600943S, RTP602165S, RTP600464S, RTP600925S, RTP601937S, RTP601856S, RTP602480S, RTP600016S, RTP600141S, RTP600187S, RTP600435S, RTP600650S, RTP600688S, RTP600825S, RTP601026S, RTP601695S, RTP601696S, RTP601852S, RTP602075S, RTP602249S, RTP602438S, RTP602460S, RTP600323S, RTP600616S, RTP600857S, RTP602960S, RTP601742S, RTP600539S, RTP601774S, RTP600080S, RTP600813S, RTP600849S, RTP600290S, RTP600401S, RTP600629S, RTP600871S, RTP600984S, RTP601861S, RTP601979S, RTP602247S, RTP602299S, RTP600789S, RTP601168S, RTP601616S, RTP601720S, RTP602470S, RTP602045S, RTP602325S, RTP602583S, RTP600625S, RTP601662S, RTP602483S, RTP600152S, RTP600153S, RTP600155S, RTP600156S, RTP600081S, RTP602115S, RTP600812S, RTP601158S, RTP602495S, RTP600936S, RTP600949S, RTP602408S, RTP602771S, RTP603024S, RTP603026S, RTP603040S, RTP603190S, RTP603237S, RTP603238S, RTP603239S, RTP603241S, RTP603242S, RTP603243S, RTP600722S, RTP600732S, RTP600759S, RTP601978S, RTP600673S, RTP601173S, RTP601888S, RTP601681S, RTP601682S, RTP602425S, RTP602631S, RTP602766S, RTP602768S, RTP602769S, RTP602770S, RTP600084S, RTP601090S, RTP602510S, RTP601115S, RTP601120S, RTP601600S, RTP601602S, RTP601699S, RTP601712S, RTP601823S, RTP601824S, RTP602173S, RTP602175S, RTP602207S, RTP602208S, RTP602209S, RTP602244S, RTP602278S, RTP602328S, RTP602331S, RTP602343S, RTP602344S, RTP602379S, RTP602543S, RTP602544S, RTP602545S, RTP602546S, RTP602547S, RTP602548S, RTP602933S, RTP602937S, RTP602939S, RTP603033S, RTP603041S, RTP603047S, RTP603232S, RTP603233S, RTP603234S, RTP603235S, RTP603245S, RTP603246S, RTP603247S, RTP603249S, RTP600082S, RTP600832S, RTP601100S, RTP600705S, RTP601943S, RTP603668S, RTP603713S, RTP600837S, RTP600178S, RTP600194S, RTP600294S, RTP600306S, RTP600486S, RTP600601S, RTP602465S, RTP600941S, RTP600963S, RTP601713S, RTP602497S, RTP600257S, RTP600416S, RTP601915S, RTP601767S, RTP602420S, RTP601983S, RTP602031S, RTP600548S, RTP600995S, RTP602424S, RTP600411S, RTP600474S, RTP601898S, RTP601581S, RTP601586S, RTP601587S, RTP601792S, RTP601809S, RTP602231S, RTP602260S, RTP602519S, RTP601828S, RTP602147S, RTP600473S, RTP600630S, RTP600842S, RTP600248S, RTP601853S, RTP602202S, RTP600979S, RTP601864S, RTP601961S, RTP602171S, RTP600282S, RTP601827S, RTP602122S, RTP601654S, RTP601718S, RTP601893S, RTP602394S, RTP601205S, RTP600381S, RTP600071S, RTP600150S, RTP601200S, RTP600090S, RTP600099S, RTP600105S, RTP600169S, RTP600438S, RTP600501S, RTP600893S, RTP601646S, RTP601922S, RTP602116S, RTP602319S, RTP602579S, RTP603541S, RTP603418S, RTP600217S, RTP601910S, RTP602018S, RTP600476S, RTP600765S, RTP600953S, RTP602512S, RTP600844S, RTP601891S, RTP602156S, RTP600975S, RTP601130S, RTP602078S, RTP602248S, RTP602306S, RTP602412S, RTP602462S, RTP602336S, RTP600075S, RTP600531S, RTP601213S, RTP600206S, RTP601149S, RTP601177S, RTP601690S, RTP602016S, RTP602258S, RTP602620S, RTP600731S, RTP600998S, RTP602042S, RTP601974S, RTP602612S, RTP600686S, RTP600613S, RTP602098S, RTP600579S, RTP600801S, RTP603626S, RTP601603S, RTP601819S, RTP600713S, RTP600500S, RTP601137S, RTP601164S, RTP601932S, RTP601935S, RTP601671S, RTP601846S, RTP600382S, RTP601204S, RTP601728S, RTP602008S, RTP602014S, RTP602020S, RTP600274S, RTP600479S, RTP600252S, RTP600521S, RTP601094S, RTP602414S, RTP602417S, RTP600287S, RTP600288S, RTP600298S, RTP601775S, RTP602314S, RTP602365S, RTP602133S, RTP601229S, RTP601074S, RTP602517S, RTP603277S, RTP600070S, RTP600729S, RTP601842S, RTP602484S, RTP602485S, RTP602590S, RTP601661S, RTP602348S, RTP602263S, RTP602295S, RTP600926S, RTP603036S, RTP603037S, RTP603038S, RTP601564S, RTP601667S, RTP601746S, RTP602136S, RTP602200S, RTP602259S, RTP602601S, RTP602602S, RTP600130S, RTP601628S, RTP601880S, RTP602419S, RTP600809S, RTP600349S, RTP602082S, RTP602392S, RTP600600S, RTP601129S, RTP601163S, RTP600571S, RTP600583S, RTP601652S, RTP601840S, RTP601841S, RTP602773S, RTP602774S, RTP603021S, RTP603022S, RTP603023S, RTP600828S, RTP600718S, RTP601562S, RTP601563S, RTP602205S, RTP602916S, RTP603004S, RTP601018S, RTP601829S, RTP602155S, RTP602177S, RTP602180S, RTP602181S, RTP602182S, RTP602183S, RTP602192S, RTP602193S, RTP602423S, RTP600529S, RTP601805S, RTP601808S, RTP601952S, RTP602186S, RTP602191S, RTP602214S, RTP602441S, RTP600233S, RTP600626S, RTP600810S, RTP601963S, RTP602428S, RTP602474S, RTP602896S, RTP602898S, RTP602899S, RTP602219S, RTP602594S, RTP602902S, RTP602903S, RTP601167S, RTP602015S, RTP602135S, RTP601010S, RTP601075S, RTP601590S, RTP601598S, RTP602385S, RTP602386S, RTP602550S, RTP602551S, RTP602582S, RTP602630S, RTP603194S, RTP603230S, RTP603323S, RTP603468S, RTP602059S, RTP601165S, RTP600072S, RTP600852S, RTP602080S, RTP602150S, RTP602279S, RTP602293S, RTP602516S, RTP602552S, RTP601700S, RTP602473S, RTP602245S, RTP600942S, RTP600180S, RTP600182S, RTP600354S, RTP600704S, RTP602134S, RTP601803S, RTP601975S, RTP602201S, RTP600222S, RTP602329S, RTP600292S, RTP600558S, RTP601207S, RTP601754S, RTP601755S, RTP602091S, RTP602521S, RTP602526S, RTP602529S, RTP602531S, RTP602532S, RTP602533S, RTP602627S, RTP602628S, RTP602629S, RTP602836S, RTP602837S, RTP602915S, RTP602927S, RTP603052S, RTP603053S, RTP601968S, RTP601969S, RTP601985S; GTIN 00763000178246, Lot Serial Numbers: RTP602975S, RTP602991S, RTP602987S, RTP602989S, RTP603706S, RTP603089S, RTP602527S, RTP602530S, RTP603005S, RTP603070S, RTP603299S, RTP601483S, RTP601462S, RTP603129S, RTP600318S, RTP600325S, RTP602976S, RTP603123S, RTP600265S, RTP603108S, RTP603291S, RTP603684S, RTP600337S, RTP601398S, RTP602660S, RTP603166S, RTP600037S, RTP602802S, RTP601443S, RTP602807S, RTP602978S, RTP603017S, RTP603675S, RTP601459S, RTP603133S, RTP601516S, RTP602842S, RTP603665S, RTP601467S, RTP602968S, RTP602974S, RTP603025S, RTP603145S, RTP601464S, RTP602671S, RTP603095S, RTP603564S, RTP603686S, RTP602792S, RTP602953S, RTP601514S, RTP603029S, RTP603560S, RTP603152S, RTP603138S, RTP602659S, RTP601374S, RTP600032S, RTP602799S, RTP601375S, RTP601377S, RTP600027S, RTP602668S, RTP603532S, RTP601381S, RTP600028S, RTP600029S, RTP600043S, RTP600046S, RTP600047S, RTP600051S, RTP600062S, RTP601371S, RTP601379S, RTP603707S, RTP601376S, RTP601380S, RTP601404S, RTP601409S, RTP601419S, RTP601496S, RTP603130S, RTP603132S, RTP603147S, RTP603148S, RTP603165S, RTP603612S, RTP603614S, RTP603691S, RTP603728S, RTP603028S, RTP602656S, RTP601454S, RTP603306S, RTP601501S, RTP601504S, RTP602528S, RTP602969S, RTP603083S, RTP603544S, RTP603547S, RTP603151S, RTP603676S, RTP600045S, RTP601410S, RTP601450S, RTP601425S, RTP603011S, RTP600022S, RTP600023S, RTP601365S, RTP601395S, RTP602973S, RTP603077S, RTP601412S, RTP600064S, RTP601389S, RTP601396S, RTP602658S, RTP602959S, RTP603062S, RTP600061S, RTP601386S, RTP601403S, RTP601414S, RTP600024S, RTP600039S, RTP600044S, RTP600055S, RTP600056S, RTP600058S, RTP601392S, RTP601394S, RTP601423S, RTP603069S, RTP601411S, RTP602793S, RTP600025S, RTP600026S, RTP600049S, RTP600015S, RTP601391S, RTP600011S, RTP602965S, RTP602967S, RTP602667S, RTP601513S, RTP601405S, RTP602524S, RTP603101S, RTP603109S, RTP603000S, RTP603019S, RTP603084S, RTP603141S, RTP603150S, RTP603168S, RTP602673S, RTP602680S, RTP601449S, RTP600370S, RTP600371S, RTP602809S, RTP600376S, RTP600363S, RTP600364S, RTP600369S, RTP601485S, RTP601518S, RTP602675S, RTP602677S, RTP602808S, RTP601452S, RTP601457S, RTP602688S, RTP602689S, RTP602833S, RTP603197S, RTP603222S, RTP601505S, RTP601491S, RTP601458S, RTP601492S, RTP600365S, RTP602679S, RTP601524S, RTP600367S, RTP601460S, RTP601512S, RTP602676S, RTP600035S, RTP601378S, RTP601383S, RTP602958S, RTP603059S, RTP601453S, RTP603671S, RTP601387S, RTP601366S, RTP601367S, RTP602663S, RTP602665S, RTP602990S, RTP600013S, RTP600014S, RTP601390S, RTP601408S, RTP602952S, RTP602956S, RTP602963S, RTP602985S, RTP601461S, RTP601393S, RTP601539S, RTP601368S, RTP601369S, RTP602998S, RTP603015S, RTP603016S, RTP601370S, RTP601446S, RTP601447S, RTP602834S, RTP602948S, RTP602983S, RTP601470S, RTP601511S, RTP601534S, RTP602981S, RTP602982S, RTP602986S, RTP602988S, RTP602997S, RTP602980S, RTP602984S, RTP602992S, RTP601444S, RTP603682S, RTP601448S, RTP601382S, RTP601384S, RTP601388S, RTP601434S, RTP601385S, RTP603745S, RTP602678S, RTP602683S, RTP602826S, RTP602971S, RTP602979S, RTP602994S, RTP603076S, RTP603087S, RTP603088S, RTP603174S, RTP603248S, RTP603594S, RTP603605S, RTP603615S, RTP603616S, RTP603652S, RTP603705S, RTP603708S, RTP603711S, RTP603723S, RTP603738S, RTP603746S, RTP603751S, RTP603753S, RTP603763S, RTP603111S, RTP603112S, RTP603118S, RTP603085S, RTP603086S, RTP603097S, RTP603305S, RTP603625S
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 800-929-4043
• Manufacturer Reason for Recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
• Quantity in Commerce: 2884 units
• Distribution: US Nationwide - Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.