Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1782-2023
• 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 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO602270S, RTO600314S, RTO601040S, RTO601383S, RTO600175S, RTO600229S, RTO600417S, RTO600458S, RTO600507S, RTO600650S, RTO601039S, RTO602060S, RTO603798S, RTO600463S, RTO601433S, RTO601826S, RTO601973S, RTO602476S, RTO601038S, RTO601148S, RTO601171S, RTO601248S, RTO602261S, RTO601481S, RTO600833S, RTO601285S, RTO601310S, RTO601556S, RTO600393S, RTO602484S, RTO600262S, RTO600681S, RTO601538S, RTO600380S, RTO600384S, RTO601944S, RTO602394S, RTO602445S, RTO600968S, RTO601037S, RTO601565S, RTO600218S, RTO601309S, RTO601311S, RTO601453S, RTO603333S, RTO600332S, RTO600493S, RTO601704S, RTO601798S, RTO601954S, RTO601983S, RTO602442S, RTO601808S, RTO601986S, RTO602037S, RTO600385S, RTO600435S, RTO601216S, RTO601220S, RTO601630S, RTO601735S, RTO601244S, RTO601307S, RTO601308S, RTO601043S, RTO602304S, RTO600445S, RTO600450S, RTO601513S, RTO601618S, RTO601942S, RTO600251S, RTO601520S, RTO600716S, RTO600464S, RTO601650S, RTO600151S, RTO600363S, RTO601008S, RTO600267S, RTO600268S, RTO600571S, RTO600605S, RTO600640S, RTO602065S, RTO600244S, RTO600634S, RTO602301S, RTO602309S, RTO600283S, RTO601834S, RTO602047S, RTO602593S, RTO601959S, RTO601109S, RTO601586S, RTO602128S, RTO602485S, RTO602486S, RTO602542S, RTO602121S, RTO600657S, RTO600729S, RTO600730S, RTO600731S, RTO601325S, RTO601490S, RTO601491S, RTO601493S, RTO601558S, RTO601560S, RTO601561S, RTO601562S, RTO601049S, RTO601118S, RTO601922S, RTO602290S, RTO602291S, RTO602579S, RTO603682S, RTO601978S, RTO602382S, RTO600717S, RTO600718S, RTO601029S, RTO601769S, RTO602005S, RTO602072S, RTO602296S, RTO600121S, RTO600321S, RTO600341S, RTO600343S, RTO600420S, RTO601165S, RTO601637S, RTO601760S, RTO601761S, RTO601817S, RTO601925S, RTO601943S, RTO601955S, RTO602073S, RTO602125S, RTO602206S, RTO602275S, RTO602286S, RTO602357S, RTO602358S, RTO602448S, RTO602455S, RTO602526S, RTO602527S, RTO602565S, RTO602566S, RTO600471S, RTO601326S, RTO601744S, RTO601823S, RTO602289S, RTO601799S, RTO601207S, RTO602351S, RTO601498S, RTO601900S, RTO602069S, RTO602362S, RTO602404S, RTO602456S, RTO602662S, RTO603744S, RTO600391S, RTO600430S, RTO601362S, RTO601708S, RTO602592S, RTO602663S, RTO600403S, RTO601643S, RTO601676S, RTO602397S, RTO600350S, RTO602490S, RTO601035S, RTO601303S, RTO602088S, RTO602491S, RTO601684S, RTO601689S, RTO600598S, RTO600352S, RTO601023S, RTO603818S, RTO601812S, RTO602137S, RTO602207S, RTO602292S, RTO602294S, RTO602369S, RTO602398S, RTO602126S, RTO600680S, RTO600546S, RTO600547S, RTO600558S, RTO600632S, RTO600633S, RTO601649S, RTO601989S, RTO600497S, RTO600404S, RTO600238S, RTO600222S, RTO600277S, RTO600278S, RTO600313S, RTO600320S, RTO600330S, RTO600501S, RTO600559S, RTO600587S, RTO600614S, RTO600660S, RTO600838S, RTO600840S, RTO601067S, RTO601124S, RTO601614S, RTO601616S, RTO602533S, RTO601820S, RTO601930S, RTO603786S, RTO601347S, RTO601856S, RTO602537S, RTO600071S, RTO600479S, RTO600740S, RTO601510S, RTO601527S, RTO601785S, RTO600397S, RTO600412S, RTO600483S, RTO600646S, RTO600647S, RTO600648S, RTO601263S, RTO600369S, RTO600485S, RTO600622S, RTO601070S, RTO601175S, RTO601176S, RTO601181S, RTO601473S, RTO600442S, RTO600528S, RTO601678S, RTO601836S, RTO602104S, RTO602105S, RTO601583S, RTO601946S, RTO602164S, RTO602426S, RTO600830S, RTO600372S, RTO600394S, RTO601670S, RTO601892S, RTO601971S, RTO600554S, RTO601471S, RTO601841S, RTO601972S, RTO601979S, RTO602014S, RTO602175S, RTO601879S, RTO600129S, RTO601512S, RTO601514S, RTO602672S, RTO601805S, RTO602488S, RTO600104S, RTO600376S, RTO600377S, RTO600253S, RTO600296S, RTO600342S, RTO601288S, RTO601786S, RTO602063S, RTO600289S, RTO600307S, RTO601446S, RTO602477S, RTO600383S, RTO601881S, RTO601521S, RTO601526S, RTO600338S, RTO601882S, RTO602136S, RTO602341S, RTO600127S, RTO601375S, RTO601545S, RTO601546S, RTO602282S, RTO602371S, RTO602373S, RTO603683S, RTO601246S, RTO601953S, RTO601563S, RTO602194S, RTO600416S, RTO600422S, RTO600592S, RTO600615S, RTO601443S, RTO601572S, RTO601604S, RTO601605S, RTO601606S, RTO601758S, RTO601180S, RTO601428S, RTO601862S, RTO600184S, RTO602443S, RTO602555S, RTO600637S, RTO601686S, RTO602367S, RTO600382S, RTO600517S, RTO600531S, RTO600562S, RTO600597S, RTO600727S, RTO600728S, RTO601087S, RTO601304S, RTO601313S, RTO601494S, RTO601516S, RTO601575S, RTO601619S, RTO601661S, RTO601663S, RTO601759S, RTO601866S, RTO601952S, RTO601999S, RTO602030S, RTO602090S, RTO602142S, RTO602269S, RTO602321S, RTO602343S, RTO602433S, RTO602538S, RTO601157S, RTO603131S, RTO601768S, RTO602100S, RTO601484S, RTO601737S, RTO601763S, RTO601775S, RTO602190S, RTO602197S, RTO602431S, RTO602551S, RTO602552S, RTO602610S, RTO601995S, RTO600335S, RTO600399S, RTO600638S, RTO600690S, RTO601700S, RTO602067S, RTO600310S, RTO601813S, RTO601984S, RTO600112S, RTO600215S, RTO600221S, RTO600235S, RTO601496S, RTO601721S, RTO601908S, RTO601919S, RTO602204S, RTO602390S, RTO602400S, RTO600738S, RTO601674S, RTO600841S, RTO602087S, RTO602520S, RTO600248S, RTO602530S, RTO600381S, RTO601062S, RTO601189S, RTO601819S, RTO601921S, RTO602368S, RTO602645S, RTO603513S, RTO600078S, RTO600560S, RTO601528S, RTO602478S, RTO603800S, RTO601958S, RTO601969S, RTO602193S, RTO601648S, RTO602183S, RTO600425S, RTO600431S, RTO600574S, RTO601479S, RTO601685S, RTO601791S, RTO602355S, RTO602393S, RTO602395S, RTO601567S, RTO600429S, RTO601332S, RTO601346S, RTO601698S, RTO601858S, RTO601665S, RTO601837S, RTO601857S, RTO603514S, RTO601083S, RTO602169S, RTO602536S, RTO600286S, RTO600287S, RTO600602S, RTO600604S, RTO601138S, RTO601151S, RTO601153S, RTO601696S, RTO601757S, RTO601865S, RTO602199S, RTO602210S, RTO602271S, RTO602287S, RTO602327S, RTO603555S, RTO601042S, RTO600113S, RTO601195S, RTO601231S, RTO600569S, RTO600703S, RTO601081S, RTO601114S, RTO601883S, RTO602211S, RTO602264S, RTO600140S, RTO600191S, RTO600195S, RTO601671S, RTO601975S, RTO602140S, RTO600739S, RTO601569S, RTO602053S, RTO603792S, RTO602177S, RTO602553S, RTO600103S, RTO600105S, RTO600199S, RTO600346S, RTO601388S, RTO601872S, RTO601893S, RTO602324S, RTO602333S, RTO602381S, RTO601100S, RTO602600S, RTO600645S, RTO600662S, RTO600667S, RTO601120S, RTO601368S, RTO601184S, RTO602376S, RTO600096S, RTO600107S, RTO600108S, RTO600130S, RTO600413S, RTO600585S, RTO600631S, RTO600699S, RTO600735S, RTO601072S, RTO601113S, RTO601116S, RTO601142S, RTO601147S, RTO601499S, RTO601522S, RTO601541S, RTO601644S, RTO601713S, RTO601714S, RTO602055S, RTO602176S, RTO602185S, RTO602195S, RTO602215S, RTO602302S, RTO602386S, RTO602407S, RTO602408S, RTO602493S, RTO602554S, RTO601838S, RTO603742S, RTO603848S, RTO603741S, RTO603359S, RTO603571S, RTO601389S, RTO601890S, RTO602285S, RTO602798S, RTO600095S, RTO601529S, RTO601593S, RTO601770S, RTO602158S, RTO602163S, RTO602284S, RTO600437S, RTO600700S, RTO601733S, RTO602172S, RTO602182S, RTO600110S, RTO600239S, RTO600241S, RTO600557S, RTO600580S, RTO600709S, RTO601355S, RTO601537S, RTO601693S, RTO602062S, RTO602077S, RTO602325S, RTO601009S, RTO601071S, RTO601645S, RTO602556S, RTO601169S, RTO601831S, RTO600154S, RTO603715S, RTO601167S, RTO601301S, RTO602015S, RTO602083S, RTO601315S, RTO600440S, RTO601146S, RTO602139S, RTO602161S, RTO600081S, RTO601680S, RTO602022S, RTO602508S, RTO602635S, RTO601079S, RTO601622S, RTO601825S, RTO603442S, RTO601656S, RTO601695S, RTO602016S, RTO601054S, RTO601426S, RTO600266S, RTO600303S, RTO600542S, RTO600545S, RTO601789S, RTO602049S, RTO600460S, RTO602003S, RTO602004S, RTO602410S, RTO602509S, RTO601599S, RTO601804S, RTO601041S, RTO601198S, RTO601966S, RTO601977S, RTO602032S, RTO602991S, RTO602993S, RTO603118S, RTO600826S, RTO600834S, RTO601844S, RTO600676S, RTO600678S, RTO603632S, RTO600159S, RTO600160S, RTO600190S, RTO600480S, RTO600481S, RTO600487S, RTO600520S, RTO601057S, RTO601098S, RTO601143S, RTO601432S, RTO601525S, RTO601566S, RTO601691S, RTO601697S, RTO601707S, RTO601717S, RTO601738S, RTO601880S, RTO602092S, RTO602274S, RTO602279S, RTO602409S, RTO602609S, RTO602295S, RTO600152S, RTO602071S, RTO600476S, RTO600671S, RTO600677S, RTO601424S, RTO601868S, RTO602057S, RTO600331S, RTO601221S, RTO601222S, RTO601228S, RTO600216S, RTO601299S, RTO601657S, RTO600312S, RTO600374S, RTO600685S, RTO600719S, RTO601193S, RTO601262S, RTO601625S, RTO601653S, RTO602303S, RTO603466S, RTO600664S, RTO600079S, RTO600333S, RTO601045S, RTO601488S, RTO601568S, RTO601570S, RTO601571S, RTO600124S, RTO600465S, RTO600567S, RTO601724S, RTO602101S, RTO600424S, RTO601928S, RTO600285S, RTO600453S, RTO600490S, RTO601238S, RTO601377S, RTO601840S, RTO602146S, RTO600139S, RTO600578S, RTO601584S, RTO601755S, RTO601859S, RTO601985S, RTO602058S, RTO602075S, RTO602403S, RTO601502S, RTO601923S, RTO602006S, RTO602156S, RTO602162S, RTO600395S, RTO600082S, RTO600203S, RTO600207S, RTO600208S, RTO600212S, RTO600224S, RTO600294S, RTO600324S, RTO600325S, RTO600362S, RTO600398S, RTO600518S, RTO600552S, RTO600555S, RTO600556S, RTO600643S, RTO600666S, RTO601085S, RTO601319S, RTO601378S, RTO601612S, RTO601747S, RTO601753S, RTO601754S, RTO601861S, RTO601867S, RTO601901S, RTO601938S, RTO602059S, RTO602076S, RTO602150S, RTO602384S, RTO602401S, RTO602479S, RTO601068S, RTO602034S, RTO602035S, RTO602036S, RTO603544S, RTO601638S, RTO601814S, RTO601894S, RTO603654S, RTO600163S, RTO600181S, RTO600182S, RTO600234S, RTO600249S, RTO600252S, RTO600255S, RTO600512S, RTO600537S, RTO600711S, RTO600724S, RTO601091S, RTO601200S, RTO601461S, RTO601577S, RTO601664S, RTO601679S, RTO601732S, RTO601795S, RTO601810S, RTO601833S, RTO601878S, RTO602011S, RTO602026S, RTO602257S, RTO602283S, RTO602331S, RTO602336S, RTO602350S, RTO602434S, RTO602458S, RTO602464S, RTO602465S, RTO602467S, RTO602640S, RTO603661S, RTO603776S, RTO603777S, RTO603801S, RTO603803S, RTO603804S, RTO600172S, RTO600311S, RTO601543S, RTO602649S, RTO601940S, RTO602529S, RTO600423S, RTO601107S, RTO601122S, RTO601380S, RTO601809S, RTO602446S, RTO603577S, RTO602170S, RTO600138S, RTO601634S, RTO603452S, RTO600553S, RTO601420S, RTO601447S, RTO601509S, RTO602258S, RTO600097S, RTO600665S, RTO600091S, RTO600099S, RTO600563S, RTO600114S, RTO600179S, RTO601132S, RTO601589S, RTO601783S, RTO600621S, RTO601515S, RTO603634S, RTO603635S, RTO600401S, RTO600527S, RTO602112S, RTO602178S, RTO602676S, RTO600126S, RTO601632S, RTO602166S, RTO602470S, RTO601647S, RTO603846S, RTO600256S, RTO600299S, RTO600414S, RTO601449S, RTO601283S, RTO601920S, RTO602512S, RTO601337S, RTO600204S, RTO601800S, RTO601876S, RTO602056S, RTO602307S, RTO601455S, RTO601607S, RTO601712S, RTO602375S, RTO602421S, RTO602422S, RTO602463S, RTO602543S, RTO602613S, RTO602620S, RTO602642S, RTO602647S, RTO603719S, RTO600093S, RTO600447S, RTO600264S, RTO601117S, RTO600421S, RTO600572S, RTO603768S, RTO600334S, RTO600723S, RTO600726S, RTO601271S, RTO601305S, RTO601373S, RTO601448S, RTO601523S, RTO601666S, RTO602387S, RTO602637S, RTO603206S, RTO603386S, RTO603394S, RTO600196S, RTO600692S, RTO601356S, RTO602402S, RTO601803S, RTO600406S, RTO601869S, RTO601127S, RTO601293S, RTO601587S, RTO601884S, RTO601965S, RTO600451S, RTO601209S, RTO601279S, RTO601682S, RTO601933S, RTO600613S, RTO601250S, RTO601598S, RTO601675S, RTO601842S, RTO602213S, RTO602214S, RTO602453S, RTO601557S, RTO600083S, RTO600258S, RTO600280S, RTO600360S, RTO600625S, RTO600652S, RTO600722S, RTO601059S, RTO601188S, RTO601208S, RTO601306S, RTO603480S, RTO600411S, RTO602764S, RTO600072S, RTO600088S, RTO600120S, RTO600733S, RTO600734S, RTO600852S, RTO601024S, RTO601115S, RTO601202S, RTO601316S, RTO601419S, RTO601427S, RTO601472S, RTO601503S, RTO601505S, RTO601508S, RTO601547S, RTO601654S, RTO601687S, RTO601796S, RTO601818S, RTO601963S, RTO600410S, RTO601106S, RTO601478S, RTO601706S, RTO601935S, RTO601994S, RTO602078S, RTO600162S, RTO601206S, RTO601425S, RTO601431S, RTO601574S, RTO601703S, RTO601773S, RTO601912S, RTO602041S, RTO602483S, RTO601445S, RTO602000S, RTO602029S, RTO602994S, RTO602995S, RTO603120S, RTO600226S, RTO601126S, RTO601318S, RTO601847S, RTO601927S, RTO602217S, RTO603790S, RTO600220S, RTO600353S, RTO600387S, RTO600443S, RTO600506S, RTO600586S, RTO600590S, RTO600591S, RTO601030S, RTO601336S, RTO601350S, RTO601600S, RTO601947S, RTO602018S, RTO602123S, RTO602337S, RTO602352S, RTO601924S, RTO602532S, RTO600515S, RTO600534S, RTO601790S, RTO600712S, RTO601011S, RTO601827S, RTO600080S, RTO600511S, RTO600513S, RTO601934S, RTO601021S, RTO600436S, RTO601532S, RTO601597S, RTO600257S, RTO602066S, RTO602612S, RTO600434S, RTO602670S, RTO600098S, RTO601101S, RTO601961S, RTO603444S, RTO601270S, RTO600693S, RTO601718S, RTO601990S, RTO602621S, RTO603655S, RTO601941S, RTO601212S, RTO601701S, RTO600583S, RTO601911S, RTO602196S, RTO602091S, RTO600288S, RTO600496S, RTO600708S, RTO600386S, RTO601756S, RTO602447S, RTO601504S, RTO601535S, RTO603815S, RTO600116S, RTO600106S, RTO600117S, RTO600144S, RTO600183S, RTO601234S, RTO603427S, RTO600201S, RTO601391S, RTO601581S, RTO602021S, RTO602181S, RTO602451S, RTO602674S, RTO602677S, RTO603234S, RTO600568S, RTO600600S, RTO600601S, RTO601792S, RTO601830S, RTO601991S, RTO602173S, RTO602329S, RTO602427S, RTO600373S, RTO601191S, RTO601275S, RTO603636S, RTO600176S, RTO602525S, RTO600526S, RTO602116S, RTO602278S, RTO603552S, RTO600137S, RTO600155S, RTO600156S, RTO600185S, RTO600532S, RTO600741S, RTO601090S, RTO601108S, RTO602472S, RTO600695S, RTO601074S, RTO601273S, RTO601312S, RTO601487S, RTO601807S, RTO602208S, RTO602650S, RTO602651S, RTO602673S, RTO603517S, RTO602308S, RTO602311S, RTO602326S, RTO602330S, RTO602372S, RTO602504S, RTO602544S, RTO602545S, RTO602562S, RTO602577S, RTO602596S, RTO602598S, RTO602681S, RTO602682S, RTO602684S, RTO602686S, RTO602744S, RTO602754S, RTO602756S, RTO602818S, RTO602821S, RTO602823S, RTO602830S, RTO602832S, RTO602836S, RTO602837S, RTO602838S, RTO602840S, RTO602843S, RTO602844S, RTO602845S, RTO602846S, RTO602847S, RTO602848S, RTO602849S, RTO602850S, RTO602852S, RTO602853S, RTO602854S, RTO602855S, RTO602858S, RTO602859S, RTO602941S, RTO602966S, RTO602967S, RTO602968S, RTO602977S, RTO602980S, RTO602983S, RTO602984S, RTO602989S, RTO602990S, RTO602997S, RTO603000S, RTO603003S, RTO603005S, RTO603007S, RTO603008S, RTO603009S, RTO603010S, RTO603011S, RTO603013S, RTO603014S, RTO603015S, RTO603019S, RTO603021S, RTO603023S, RTO603074S, RTO603075S, RTO603076S, RTO603077S, RTO603078S, RTO603085S, RTO603087S, RTO603089S, RTO603091S, RTO603092S, RTO603097S, RTO603111S, RTO603170S, RTO603207S, RTO603219S, RTO603252S, RTO603284S, RTO603311S, RTO603321S, RTO603327S, RTO603329S, RTO603332S, RTO603383S, RTO603384S, RTO603385S, RTO603391S, RTO603392S, RTO603566S, RTO603569S, RTO603572S, RTO603576S, RTO603630S, RTO603631S, RTO603633S, RTO600157S, RTO600169S, RTO600486S, RTO600698S, RTO601019S, RTO601088S, RTO601135S, RTO602683S, RTO602687S, RTO602688S, RTO602689S, RTO602690S, RTO602691S, RTO602693S, RTO602695S, RTO602697S, RTO602698S, RTO602699S, RTO602701S, RTO602703S, RTO602707S, RTO602708S, RTO602710S, RTO602711S, RTO602716S, RTO602718S, RTO602721S, RTO602723S, RTO602726S, RTO602727S, RTO602728S, RTO602729S, RTO602730S, RTO602731S, RTO602732S, RTO602733S, RTO602736S, RTO602737S, RTO602738S, RTO602739S, RTO602742S, RTO602743S, RTO602745S, RTO602746S, RTO602747S, RTO602748S, RTO602750S, RTO602752S, RTO602757S, RTO602758S, RTO602759S, RTO602761S, RTO602762S, RTO602763S, RTO602765S, RTO602766S, RTO602767S, RTO602768S, RTO602770S, RTO602771S, RTO602772S, RTO602774S, RTO602775S, RTO602779S, RTO602780S, RTO602783S, RTO602785S, RTO602791S, RTO602793S, RTO602797S, RTO602802S, RTO602803S, RTO602805S, RTO602806S, RTO602808S, RTO602809S, RTO602810S, RTO602811S, RTO602812S, RTO602813S, RTO602814S, RTO602815S, RTO602816S, RTO602817S, RTO602819S, RTO602822S, RTO602824S, RTO602827S, RTO602829S, RTO602860S, RTO602862S, RTO602863S, RTO602864S, RTO602865S, RTO602866S, RTO602867S, RTO602868S, RTO602869S, RTO602870S, RTO602871S, RTO602872S, RTO602873S, RTO602874S, RTO602875S, RTO602876S, RTO602878S, RTO602879S, RTO602880S, RTO602881S, RTO602882S, RTO602883S, RTO602884S, RTO602885S, RTO602886S, RTO602887S, RTO602888S, RTO602889S, RTO602890S, RTO602891S, RTO602892S, RTO602893S, RTO602894S, RTO602895S, RTO602896S, RTO602898S, RTO602899S, RTO602900S, RTO602901S, RTO602902S, RTO602903S, RTO602904S, RTO602906S, RTO602907S, RTO602908S, RTO602909S, RTO602910S, RTO602911S, RTO602912S, RTO602913S, RTO602916S, RTO602917S, RTO602918S, RTO602920S, RTO602921S, RTO602922S, RTO602923S, RTO602924S, RTO602926S, RTO602927S, RTO602928S, RTO602929S, RTO602930S, RTO602931S, RTO602932S, RTO602934S, RTO602935S, RTO602936S, RTO602937S, RTO602938S, RTO602939S, RTO602942S, RTO602943S, RTO602944S, RTO602945S, RTO602946S, RTO602947S, RTO602948S, RTO602949S, RTO602950S, RTO602951S, RTO602952S, RTO602953S, RTO602954S, RTO602955S, RTO602956S, RTO602957S, RTO602958S, RTO602959S, RTO602960S, RTO602961S, RTO602962S, RTO602963S, RTO602964S, RTO602965S, RTO602969S, RTO602970S, RTO602971S, RTO602974S, RTO602976S, RTO602979S, RTO602981S, RTO602982S, RTO602987S, RTO602996S, RTO603004S, RTO603079S, RTO603080S, RTO603081S, RTO603103S, RTO603104S, RTO603105S, RTO603106S, RTO603107S, RTO603109S, RTO603110S, RTO603112S, RTO603113S, RTO603114S, RTO603115S, RTO603116S, RTO603117S, RTO603121S, RTO603122S, RTO603126S, RTO603143S, RTO603172S, RTO603173S, RTO603175S, RTO603176S, RTO603177S, RTO603179S, RTO603181S, RTO603183S, RTO603184S, RTO603186S, RTO603187S, RTO603188S, RTO603189S, RTO603190S, RTO603191S, RTO603192S, RTO603194S, RTO603201S, RTO603202S, RTO603203S, RTO603204S, RTO603205S, RTO603208S, RTO603209S, RTO603210S, RTO603211S, RTO603212S, RTO603213S, RTO603214S, RTO603215S, RTO603216S, RTO603218S, RTO603221S, RTO603222S, RTO603223S, RTO603224S, RTO603225S, RTO603226S, RTO603227S, RTO603228S, RTO603229S, RTO603230S, RTO603231S, RTO603232S, RTO603233S, RTO603235S, RTO603237S, RTO603238S, RTO603239S, RTO603240S, RTO603241S, RTO603242S, RTO603243S, RTO603244S, RTO603246S, RTO603248S, RTO603249S, RTO603250S, RTO603251S, RTO603255S, RTO603257S, RTO603258S, RTO603259S, RTO603260S, RTO603261S, RTO603262S, RTO603264S, RTO603265S, RTO603266S, RTO603268S, RTO603269S, RTO603270S, RTO603272S, RTO603335S, RTO603336S, RTO603337S, RTO603338S, RTO603339S, RTO603341S, RTO603342S, RTO603343S, RTO603344S, RTO603347S, RTO603348S, RTO603349S, RTO603350S, RTO603351S, RTO603352S, RTO603353S, RTO603358S, RTO603360S, RTO603361S, RTO603362S, RTO603366S, RTO603368S, RTO603369S, RTO603370S, RTO603371S, RTO603374S, RTO603376S, RTO603378S, RTO603379S, RTO603380S, RTO603381S, RTO603382S, RTO603388S, RTO603389S, RTO603395S, RTO603397S, RTO603398S, RTO603400S, RTO603401S, RTO603402S, RTO603403S, RTO603405S, RTO603406S, RTO603407S, RTO603408S, RTO603411S, RTO603412S, RTO603416S, RTO603418S, RTO603420S, RTO603421S, RTO603422S, RTO603424S, RTO603425S, RTO603428S, RTO603430S, RTO603431S, RTO603432S, RTO603433S, RTO603434S, RTO603435S, RTO603436S, RTO603437S, RTO603438S, RTO603440S, RTO603441S, RTO603443S, RTO603445S, RTO603446S, RTO603447S, RTO603448S, RTO603449S, RTO603450S, RTO603451S, RTO603453S, RTO603455S, RTO603456S, RTO603458S, RTO603462S, RTO603468S, RTO603469S, RTO603470S, RTO603471S, RTO603472S, RTO603473S, RTO603474S, RTO603475S, RTO603476S, RTO603477S, RTO603479S, RTO603481S, RTO603482S, RTO603483S, RTO603485S, RTO603486S, RTO603487S, RTO603488S, RTO603490S, RTO603491S, RTO603494S, RTO603500S, RTO603501S, RTO603502S, RTO603511S, RTO603515S, RTO603516S, RTO603518S, RTO603520S, RTO603521S, RTO603523S, RTO603525S, RTO603528S, RTO603529S, RTO603530S, RTO603535S, RTO603536S, RTO603537S, RTO603538S, RTO603539S, RTO603541S, RTO603542S, RTO603543S, RTO603548S, RTO603549S, RTO603550S, RTO603553S, RTO603554S, RTO603556S, RTO603562S, RTO603563S, RTO603564S, RTO603565S, RTO603567S, RTO603570S, RTO603574S, RTO603638S, RTO603642S, RTO603643S, RTO603646S, RTO603649S, RTO603651S, RTO603652S, RTO603653S, RTO603660S, RTO603664S, RTO603666S, RTO603668S, RTO603674S, RTO603676S, RTO603679S, RTO603685S, RTO603686S, RTO603687S, RTO603691S, RTO603692S, RTO603693S, RTO603694S, RTO603695S, RTO603698S, RTO603701S, RTO603704S, RTO603710S, RTO603714S, RTO603717S, RTO603720S, RTO603722S, RTO603723S, RTO603725S, RTO603729S, RTO603730S, RTO603731S, RTO603736S, RTO603750S, RTO603763S, RTO603764S, RTO603765S, RTO603775S, RTO603796S, RTO603797S, RTO601629S, RTO601926S, RTO602202S, RTO602999S, RTO603162S, RTO600707S, RTO600427S, RTO602097S, RTO600293S, RTO600588S, RTO600654S, RTO601719S, RTO602641S, RTO601097S, RTO601372S, RTO600549S, RTO601677S, RTO601852S, RTO602050S, RTO602224S, RTO602340S, RTO602379S, RTO602380S, RTO602399S, RTO602452S, RTO602617S, RTO602665S, RTO603773S, RTO603837S, RTO603753S, RTO600347S, RTO602317S, RTO600315S, RTO602293S, RTO600128S, RTO600503S, RTO601156S, RTO602383S, RTO601183S, RTO600539S, RTO601771S, RTO601450S, RTO600577S, RTO601076S, RTO601363S, RTO601437S, RTO602354S, RTO600171S, RTO601032S, RTO601149S, RTO601324S, RTO601469S, RTO601470S, RTO601580S, RTO601582S, RTO601588S, RTO602265S, RTO602319S, RTO602389S, RTO602539S, RTO600232S, RTO600236S, RTO600701S, RTO601204S, RTO601578S, RTO602638S, RTO601225S, RTO600142S, RTO600441S, RTO601213S, RTO601904S, RTO600715S, RTO600231S, RTO600233S, RTO600706S, RTO601742S, RTO601899S, RTO601932S, RTO602338S, RTO601047S, RTO601895S, RTO600672S, RTO600682S, RTO601596S, RTO601730S, RTO602019S, RTO602256S, RTO602388S, RTO602460S, RTO602462S, RTO602334S, RTO600736S, RTO601236S, RTO601829S, RTO600340S, RTO601898S, RTO600174S, RTO600368S, RTO602534S, RTO600243S, RTO600663S, RTO600836S, RTO601740S, RTO601811S, RTO601897S, RTO601939S, RTO601970S, RTO602028S, RTO602111S, RTO602171S, RTO602318S, RTO602320S, RTO602639S, RTO600092S, RTO601093S, RTO602074S, RTO602160S, RTO602492S, RTO601590S, RTO601591S, RTO601592S, RTO601075S, RTO601302S, RTO600304S, RTO601105S, RTO601623S, RTO601914S, RTO600658S, RTO602154S, RTO600536S, RTO601843S, RTO600635S, RTO600696S, RTO600697S, RTO600907S, RTO601766S, RTO601948S, RTO602099S, RTO602127S, RTO602153S, RTO602424S, RTO602571S, RTO602616S, RTO602619S, RTO601720S, RTO601064S, RTO600200S, RTO600211S, RTO600213S, RTO602591S, RTO600589S, RTO602363S, RTO602365S, RTO600618S, RTO600684S, RTO601544S, RTO603832S, RTO602149S, RTO600173S, RTO601849S, RTO600581S, RTO600656S, RTO601387S, RTO601476S, RTO601559S, RTO602001S, RTO602098S, RTO602102S, RTO602107S, RTO601931S, RTO603256S, RTO600433S, RTO601034S, RTO600194S, RTO600694S, RTO601134S, RTO601352S, RTO601357S, RTO601579S, RTO601672S, RTO601694S, RTO602277S, RTO601511S, RTO601729S, RTO600469S, RTO600651S, RTO600844S, RTO600847S, RTO601551S, RTO601552S, RTO603732S, RTO603774S, RTO601086S, RTO601845S, RTO600533S, RTO602212S, RTO601111S, RTO600505S, RTO601219S, RTO601992S, RTO601709S, RTO601853S, RTO603334S, RTO600466S, RTO600468S, RTO601061S, RTO601886S, RTO600603S, RTO600356S, RTO602089S, RTO602385S, RTO600477S, RTO601136S, RTO601192S, RTO601199S, RTO600570S, RTO600720S, RTO601381S, RTO602168S, RTO602396S, RTO602457S, RTO602480S, RTO602482S, RTO602589S, RTO603650S, RTO600392S, RTO600616S, RTO601746S, RTO601851S, RTO602013S, RTO602614S, RTO601752S, RTO601903S, RTO602310S, RTO600499S, RTO600617S, RTO601053S, RTO601765S, RTO601033S, RTO602192S, RTO600270S, RTO602643S, RTO602646S, RTO600619S, RTO600390S, RTO600509S, RTO601232S, RTO601297S, RTO601320S, RTO601640S, RTO601950S, RTO601110S, RTO600489S, RTO600713S, RTO600714S, RTO601129S, RTO601223S, RTO602281S, RTO602342S, RTO602459S, RTO602023S, RTO602039S, RTO601137S, RTO601239S, RTO601331S, RTO601361S, RTO601474S, RTO601506S, RTO601507S, RTO601662S, RTO601727S, RTO601774S, RTO601492S, RTO601601S, RTO601725S, RTO601726S, RTO601750S, RTO601987S, RTO601906S, RTO600494S, RTO600608S, RTO601871S, RTO601896S, RTO601945S, RTO602186S, RTO600135S, RTO601296S, RTO600737S, RTO600686S, RTO602027S, RTO602266S, RTO602297S, RTO600550S, RTO600582S, RTO601745S, RTO601891S, RTO601915S, RTO602364S, RTO600134S, RTO601272S, RTO600326S, RTO601069S, RTO600828S, RTO602138S, RTO602042S, RTO600322S, RTO600339S, RTO600829S, RTO602124S, RTO601554S, RTO601824S, RTO600291S, RTO600329S, RTO600336S, RTO602120S, RTO602260S, RTO601887S, RTO601902S, RTO602189S, RTO602191S, RTO602322S, RTO600164S, RTO601536S, RTO601660S, RTO601781S, RTO602144S, RTO601564S, RTO600292S, RTO602648S, RTO600214S, RTO600627S, RTO601788S, RTO603578S, RTO603579S, RTO603580S, RTO603581S, RTO603582S, RTO603583S, RTO603584S, RTO603585S, RTO603586S, RTO603587S, RTO603588S, RTO603604S, RTO603628S, RTO603629S, RTO602033S, RTO600210S, RTO600488S, RTO601518S, RTO601936S, RTO600351S, RTO600428S, RTO600478S, RTO601615S, RTO601620S, RTO601801S, RTO602038S, RTO600158S, RTO600178S, RTO600655S, RTO601542S, RTO601772S, RTO602046S, RTO603559S, RTO603560S, RTO600187S, RTO600302S, RTO600438S, RTO600514S, RTO600594S, RTO600596S, RTO600624S, RTO600689S, RTO601722S, RTO601962S, RTO602043S, RTO602114S, RTO602115S, RTO602151S, RTO602152S, RTO602392S, RTO602510S, RTO602567S, RTO602595S, RTO602633S, RTO602634S, RTO600263S, RTO602040S, RTO601247S, RTO601376S, RTO601949S, RTO602084S, RTO603294S, RTO603354S, RTO600358S, RTO600721S, RTO600629S, RTO601327S, RTO600407S, RTO600408S, RTO600510S, RTO600659S, RTO601710S, RTO600186S, RTO600355S, RTO600357S, RTO600492S, RTO600679S, RTO601155S, RTO601497S, RTO601617S, RTO601888S, RTO602273S, RTO602636S, RTO600359S, RTO602184S, RTO600565S, RTO601864S, RTO602391S, RTO600086S, RTO601702S, RTO600432S, RTO601354S, RTO601762S, RTO601576S, RTO600609S, RTO601158S, RTO601485S, RTO601530S, RTO601651S, RTO601723S, RTO601815S, RTO601889S, RTO602200S, RTO602423S, RTO600470S, RTO602312S, RTO601937S, RTO602528S, RTO601056S, RTO601482S, RTO601603S, RTO601688S, RTO600284S, RTO602489S, RTO600197S, RTO600198S, RTO601533S, RTO601534S, RTO600084S, RTO600089S, RTO600653S, RTO600661S, RTO600673S, RTO600691S, RTO601821S, RTO601822S, RTO602511S, RTO602061S, RTO602141S, RTO601025S, RTO601980S, RTO602428S, RTO602487S, RTO601154S, RTO601850S, RTO600813S, RTO601621S, RTO601358S, RTO600409S, RTO600482S, RTO601031S, RTO602444S, RTO602546S, RTO602561S, RTO602666S, RTO602668S, RTO603171S, RTO603199S, RTO603355S, RTO601797S, RTO601909S, RTO601960S, RTO602667S, RTO602669S, RTO601243S, RTO601245S, RTO601249S, RTO601255S, RTO602129S, RTO602339S, RTO602405S, RTO602406S, RTO602516S, RTO602517S, RTO602547S, RTO602548S, RTO602549S, RTO602550S, RTO602611S, RTO602623S, RTO602624S, RTO602625S, RTO602626S, RTO602851S, RTO602856S, RTO603322S, RTO603323S, RTO603326S, RTO603330S, RTO600143S, RTO601870S, RTO600710S, RTO601063S, RTO601539S, RTO601540S, RTO602475S, RTO602599S, RTO602601S, RTO602618S, RTO602679S, RTO602680S, RTO602985S, RTO602986S, RTO603022S, RTO603271S, RTO603305S, RTO603306S, RTO603307S, RTO603308S, RTO603309S, RTO603313S, RTO603314S, RTO603315S, RTO603316S, RTO603317S, RTO603319S, RTO603320S, RTO600418S, RTO600688S, RTO601777S, RTO601778S, RTO601793S, RTO602521S, RTO603834S, RTO603853S, RTO600344S, RTO601194S, RTO602606S, RTO601981S, RTO602054S, RTO600498S, RTO601501S, RTO601517S, 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RTO601997S, RTO602348S, RTO600523S, RTO602068S, RTO602474S, RTO602359S, RTO602370S, RTO601835S, RTO602344S, RTO600529S, RTO601395S, RTO600260S, RTO600295S, RTO600641S, RTO603659S, RTO600474S, RTO600475S, RTO601832S, RTO602025S, RTO601230S, RTO601741S, RTO601046S, RTO601051S, RTO602147S, RTO600273S, RTO601366S, RTO601434S, RTO601495S, RTO601652S, RTO601705S, RTO601854S, RTO601993S, RTO602471S, RTO600131S, RTO600389S, RTO601082S, RTO600209S, RTO600454S, RTO600473S, RTO600636S, RTO601464S, RTO601633S, RTO602064S, RTO602263S, RTO601642S, RTO601767S, RTO601964S, RTO601996S, RTO600415S, RTO601874S, RTO602048S, RTO602590S, RTO600456S, RTO600274S, RTO600068S, RTO600484S, RTO601152S, RTO601668S, RTO601669S, RTO602148S, RTO602466S, RTO600419S, RTO603573S, RTO601918S, RTO602429S, RTO601968S, RTO602411S, RTO602413S, RTO602523S, RTO602524S, RTO602569S, RTO602857S, RTO602915S, RTO602978S, RTO603001S, RTO603002S, RTO603098S, RTO603099S, RTO603100S, RTO603101S, RTO603102S, RTO603161S, RTO600192S, 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RTO602020S, RTO602108S, RTO602188S, RTO602720S, RTO601205S, RTO603018S, RTO600337S, RTO601103S, RTO601692S, RTO601065S, RTO601555S, RTO601130S, RTO602441S, RTO602519S, RTO602563S, RTO602572S, RTO602627S, RTO602629S, RTO603688S, RTO603795S, RTO603812S, RTO603854S, RTO603856S, RTO603857S, RTO601012S, RTO601013S, RTO601014S, RTO601015S, RTO601017S, RTO601150S, RTO600075S, RTO601066S, RTO602276S, RTO600348S, RTO602315S, RTO601489S, RTO602134S, RTO601779S, RTO601780S, RTO601782S, RTO602080S, RTO602081S, RTO602082S, RTO602094S, RTO602095S, RTO602179S, RTO602180S, RTO602201S, RTO602288S, RTO602323S, RTO602361S, RTO602366S, RTO602436S, RTO602437S, RTO602438S, RTO602495S, RTO602496S, RTO602498S, RTO602499S, RTO602501S, RTO602502S, RTO602503S, RTO602506S, RTO602507S, RTO602573S, RTO602574S, RTO602575S, RTO602576S, RTO602580S, RTO602581S, RTO602582S, RTO602583S, RTO602584S, RTO602585S, RTO602586S, RTO602587S, RTO602604S, RTO602605S, RTO602652S, RTO602653S, RTO602654S, RTO602655S, RTO602656S, RTO602657S, RTO602658S, RTO602659S, RTO602660S, RTO602661S, RTO602842S, RTO603012S, RTO603020S, RTO603084S, RTO603086S, RTO603088S, RTO603090S, RTO603093S, RTO603094S, RTO603095S, RTO603096S, RTO603273S, RTO603274S, RTO603276S, RTO603277S, RTO603280S, RTO602113S; GTIN 00763000178239, Lot Serial Numbers: RTO602972S, RTO602773S, RTO603128S, RTO603142S, RTO603053S, RTO601133S, RTO602299S, RTO603068S, RTO603073S, RTO603465S, RTO600045S, RTO601022S, RTO601374S, RTO601398S, RTO601016S, RTO603129S, RTO600983S, RTO603123S, RTO602497S, RTO602615S, RTO602454S, RTO602602S, RTO603399S, RTO603457S, RTO601282S, RTO601379S, RTO603057S, RTO603138S, RTO603396S, RTO603504S, RTO603055S, RTO602833S, RTO603624S, RTO603046S, RTO602841S, RTO602877S, RTO603373S, RTO601396S, RTO603043S, RTO602933S, RTO602831S, RTO602225S, RTO601256S, RTO601233S, RTO601268S, RTO601284S, RTO601344S, RTO602254S, RTO602603S, RTO603061S, RTO603289S, RTO603419S, RTO604085S, RTO603059S, RTO600988S, RTO600989S, RTO601300S, RTO601185S, RTO601252S, RTO603066S, RTO603547S, RTO603612S, RTO600977S, RTO601291S, RTO602218S, RTO600966S, RTO602518S, RTO600973S, RTO601386S, RTO601392S, RTO600033S, RTO601401S, RTO602777S, RTO603410S, RTO603413S, RTO603498S, RTO603503S, RTO603198S, RTO603217S, RTO603367S, RTO603372S, RTO602187S, RTO603026S, RTO603029S, RTO600043S, RTO600061S, RTO603508S, RTO601253S, RTO601393S, RTO602694S, RTO603623S, RTO603281S, RTO603182S, RTO602230S, RTO603278S, RTO602419S, RTO603028S, RTO601397S, RTO602500S, RTO603495S, RTO601439S, RTO602417S, RTO603027S, RTO601342S, RTO602789S, RTO603025S, RTO603185S, RTO603193S, RTO600960S, RTO603062S, RTO602220S, RTO602414S, RTO602786S, RTO603038S, RTO600055S, RTO600975S, RTO601211S, RTO601241S, RTO601281S, RTO601323S, RTO601418S, RTO602243S, RTO602700S, RTO602790S, RTO603426S, RTO600029S, RTO600038S, RTO600040S, RTO600042S, RTO601164S, RTO602228S, RTO600034S, RTO600041S, RTO600047S, RTO600051S, RTO600054S, RTO600974S, RTO601092S, RTO601099S, RTO601162S, RTO601292S, RTO601298S, RTO601399S, RTO601456S, RTO602235S, RTO602236S, RTO602247S, RTO602692S, RTO603042S, RTO603282S, RTO603463S, RTO603602S, RTO602219S, RTO601338S, RTO600049S, RTO600984S, RTO600985S, RTO600986S, RTO601010S, RTO601104S, RTO601226S, RTO601254S, RTO601257S, RTO601269S, RTO601459S, RTO602252S, RTO602253S, RTO602531S, RTO602644S, RTO602776S, RTO602792S, RTO603051S, RTO603052S, RTO600031S, RTO601251S, RTO602608S, RTO603124S, RTO600036S, RTO600037S, RTO600046S, RTO601172S, RTO601264S, RTO603040S, RTO603136S, RTO601265S, RTO601290S, RTO602227S, RTO602505S, RTO600048S, RTO600050S, RTO600053S, RTO600057S, RTO600970S, RTO602248S, RTO602349S, RTO600030S, RTO600058S, RTO601168S, RTO602221S, RTO603039S, RTO600028S, RTO600064S, RTO602778S, RTO602782S, RTO603064S, RTO603606S, RTO602237S, RTO602255S, RTO600906S, RTO603041S, RTO603275S, RTO603493S, RTO600052S, RTO601435S, RTO603058S, RTO603375S, RTO603133S, RTO603505S, RTO601442S, RTO601444S, RTO600972S, RTO602751S, RTO600978S, RTO600980S, RTO601462S, RTO600067S, RTO600606S, RTO600967S, RTO600971S, RTO601403S, RTO602741S, RTO602794S, RTO602795S, RTO601018S, RTO601414S, RTO601415S, RTO602735S, RTO602740S, RTO602801S, RTO602828S, RTO603151S, RTO603156S, RTO603157S, RTO603160S, RTO600136S, RTO601402S, RTO602804S, RTO602825S, RTO601411S, RTO602753S, RTO602800S, RTO601440S, RTO601466S, RTO601467S, RTO602820S, RTO602313S, RTO602607S, RTO601267S, RTO601360S, RTO601364S, RTO602826S, RTO602734S, RTO601345S, RTO601976S, RTO602231S, RTO602449S, RTO602450S, RTO602514S, RTO603049S, RTO600069S, RTO600070S, RTO601077S, RTO601370S, RTO601371S, RTO600056S, RTO600062S, RTO601217S, RTO601278S, RTO601280S, RTO601417S, RTO602541S, RTO603045S, RTO602787S, RTO602223S, RTO602835S, RTO603464S, RTO602242S, RTO602704S, RTO602705S, RTO602713S, RTO602714S, RTO602715S, RTO602717S, RTO602722S, RTO601365S, RTO601957S, RTO602232S, RTO602233S, RTO602234S, RTO602240S, RTO602241S, RTO602696S, RTO602238S, RTO602239S, RTO602706S, RTO602709S, RTO602712S, RTO602724S, RTO602725S, RTO602769S, RTO603144S, RTO603145S, RTO603148S, RTO603150S, RTO601400S, RTO603067S, RTO603607S, RTO602473S, RTO600060S, RTO601258S, RTO601274S, RTO602246S, RTO603032S, RTO603119S, RTO601333S, RTO602784S, RTO602788S, RTO603030S, RTO603031S, RTO602702S, RTO602760S, RTO602781S, RTO602834S, RTO603033S, RTO603047S, RTO603127S, RTO603130S, RTO603141S, RTO603152S, RTO603167S, RTO603178S, RTO603180S, RTO603279S, RTO603301S, RTO603304S, RTO603310S, RTO603312S, RTO603325S, RTO603328S, RTO603331S, RTO603340S, RTO603551S, RTO603589S, RTO603603S, RTO603605S, RTO603614S, RTO603620S, RTO603621S, RTO603808S, RTO603810S, RTO603813S, RTO603814S, RTO603816S, RTO604047S, RTO604052S, RTO602272S, RTO602332S, RTO602378S, RTO602412S, RTO603625S, RTO603626S, RTO603839S, RTO602481S, RTO603149S, RTO603197S, RTO603393S, RTO603820S, RTO603988S
• 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: 2968 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.