Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1778-2023
• Recall Event ID: 92328
• PMA Number: P010031S674
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD602419S, RTD601286S, RTD600407S, RTD600686S, RTD600687S, RTD600688S, RTD600689S, RTD601807S, RTD602096S, RTD602321S, RTD601977S, RTD600375S, RTD600427S, RTD600818S, RTD601290S, RTD601294S, RTD601304S, RTD603210S, RTD601610S, RTD601791S, RTD600469S, RTD601931S, RTD601498S, RTD601499S, RTD601778S, RTD602158S, RTD602232S, RTD602015S, RTD602249S, RTD603182S, RTD601298S, RTD600498S, RTD603371S, RTD600756S, RTD602093S, RTD601471S, RTD601517S, RTD601525S, RTD601526S, RTD601532S, RTD601534S, RTD601535S, RTD601551S, RTD601552S, RTD601843S, RTD601844S, RTD601846S, RTD601849S, RTD601851S, RTD601852S, RTD601853S, RTD601855S, RTD601857S, RTD601858S, RTD601859S, RTD601861S, RTD601862S, RTD601878S, RTD601895S, RTD601907S, RTD601913S, RTD601914S, RTD601915S, RTD601916S, RTD601933S, RTD601935S, RTD601936S, RTD601937S, RTD601942S, RTD601985S, RTD602052S, RTD602053S, RTD602054S, RTD602055S, RTD602056S, RTD602058S, RTD602059S, RTD602060S, RTD602061S, RTD602062S, RTD602063S, RTD602064S, RTD602065S, RTD602066S, RTD602067S, RTD602272S, RTD602273S, RTD602274S, RTD602276S, RTD602278S, RTD602279S, RTD602280S, RTD602281S, RTD602282S, RTD602283S, RTD602284S, RTD602285S, RTD602287S, RTD602288S, RTD602289S, RTD602291S, RTD602292S, RTD602293S, RTD602294S, RTD602295S, RTD602296S, RTD602297S, RTD602298S, RTD603153S, RTD603945S, RTD603947S, RTD603949S, RTD603950S, RTD604012S, RTD604013S, RTD604014S, RTD600837S, RTD601307S, RTD601309S, RTD601447S, RTD601448S, RTD601644S, RTD601659S, RTD601661S, RTD601665S, RTD601695S, RTD601696S, RTD601713S, RTD601714S, RTD601715S, RTD601728S, RTD600709S, RTD601438S, RTD601472S, RTD602397S, RTD603911S, RTD600434S, RTD600398S, RTD600413S, RTD600562S, RTD600583S, RTD600744S, RTD601340S, RTD601683S, RTD601711S, RTD602013S, RTD603410S, RTD603411S, RTD603502S, RTD601460S, RTD602234S, RTD602268S, RTD601367S, RTD601423S, RTD602111S, RTD602132S, RTD600527S, RTD600652S, RTD600733S, RTD601356S, RTD601382S, RTD601516S, RTD601688S, RTD601751S, RTD601824S, RTD601973S, RTD602113S, RTD601775S, RTD601823S, RTD601946S, RTD601975S, RTD601976S, RTD602307S, RTD602448S, RTD602450S, RTD603243S, RTD604037S, RTD600512S, RTD600656S, RTD600679S, RTD600598S, RTD600378S, RTD601443S, RTD601444S, RTD601445S, RTD602540S, RTD602277S, RTD602290S, RTD602411S, RTD603333S, RTD602000S, RTD601422S, RTD600711S, RTD600503S, RTD601334S, RTD600801S, RTD600814S, RTD601336S, RTD601501S, RTD603204S, RTD603205S, RTD602403S, RTD600385S, RTD601925S, RTD601930S, RTD601963S, RTD601982S, RTD602032S, RTD602033S, RTD602034S, RTD602035S, RTD602303S, RTD602304S, RTD602347S, RTD603784S, RTD603936S, RTD600371S, RTD600405S, RTD600406S, RTD600433S, RTD600442S, RTD600493S, RTD600505S, RTD600509S, RTD600519S, RTD600570S, RTD600582S, RTD600591S, RTD600597S, RTD600668S, RTD600811S, RTD600850S, RTD601441S, RTD601481S, RTD601746S, RTD601811S, RTD601965S, RTD602095S, RTD602146S, RTD602147S, RTD602239S, RTD602261S, RTD602267S, RTD603203S, RTD600381S, RTD600412S, RTD600550S, RTD600607S, RTD600747S, RTD600748S, RTD600841S, RTD601409S, RTD601410S, RTD604007S, RTD601311S, RTD600408S, RTD600775S, RTD600803S, RTD600805S, RTD601333S, RTD602682S, RTD602957S, RTD601514S, RTD600759S, RTD601798S, RTD601818S, RTD602157S, RTD600794S, RTD601978S, RTD601979S, RTD602049S, RTD602050S, RTD602051S, RTD602355S, RTD602356S, RTD602357S, RTD602358S, RTD602359S, RTD602454S, RTD602455S, RTD602457S, RTD601616S, RTD602398S, RTD602404S, RTD601660S, RTD600736S, RTD600590S, RTD600693S, RTD602012S, RTD601297S, RTD601497S, RTD602322S, RTD602337S, RTD601780S, RTD600396S, RTD600658S, RTD601641S, RTD601692S, RTD601702S, RTD601745S, RTD602326S, RTD602381S, RTD601337S, RTD601635S, RTD601651S, RTD601943S, RTD601967S, RTD602446S, RTD601407S, RTD601488S, RTD601575S, RTD602328S, RTD602379S, RTD601748S, RTD602027S, RTD603200S, RTD601530S, RTD600639S, RTD601779S, RTD601632S, RTD603180S, RTD600578S, RTD600713S, RTD600222S, RTD600812S, RTD601486S, RTD601667S, RTD601690S, RTD601722S, RTD602367S, RTD601966S, RTD602019S, RTD600425S, RTD603979S, RTD601308S, RTD601510S, RTD601666S, RTD601788S, RTD602339S, RTD602390S, RTD602391S, RTD602958S, RTD604063S, RTD602837S, RTD602393S, RTD602242S, RTD600410S, RTD601489S, RTD600761S, RTD601400S, RTD602427S, RTD600829S, RTD602327S, RTD600735S, RTD601310S, RTD602250S, RTD601938S, RTD601762S, RTD603731S, RTD600417S, RTD600500S, RTD600504S, RTD600636S, RTD600791S, RTD600820S, RTD602388S, RTD601314S, RTD602329S, RTD602031S, RTD603723S, RTD603207S, RTD603724S, RTD601284S, RTD601285S, RTD601451S, RTD601750S, RTD601479S, RTD602248S, RTD602426S, RTD602306S, RTD602348S, RTD600730S, RTD603017S, RTD603714S, RTD603728S, RTD603730S, RTD600771S, RTD601317S, RTD601573S, RTD604032S, RTD601934S, RTD601815S, RTD604064S, RTD601838S, RTD602048S, RTD602118S, RTD602139S, RTD603975S, RTD602396S, RTD601814S, RTD601723S, RTD600784S, RTD601792S, RTD602009S, RTD602323S, RTD602229S, RTD601830S, RTD601503S, RTD602316S, RTD603716S, RTD602409S, RTD602410S, RTD602913S, RTD600415S, RTD601708S, RTD601813S, RTD600743S, RTD600819S, RTD600836S, RTD601335S, RTD602237S, RTD600675S, RTD601345S, RTD601346S, RTD601349S, RTD601562S, RTD601563S, RTD601636S, RTD601730S, RTD601752S, RTD601918S, RTD602150S, RTD602151S, RTD602400S, RTD602401S, RTD604009S, RTD604042S, RTD600387S, RTD601467S, RTD601558S, RTD601836S, RTD601841S, RTD602091S, RTD603158S, RTD603163S, RTD600422S, RTD601671S, RTD600485S, RTD601810S, RTD601415S, RTD601420S, RTD601433S, RTD601614S, RTD601781S, RTD601964S, RTD601464S, RTD601738S, RTD601719S, RTD603841S, RTD601622S, RTD601989S, RTD602116S, RTD603225S, RTD600437S, RTD601312S, RTD601808S, RTD602791S, RTD603966S, RTD602942S, RTD602826S, RTD602399S, RTD600828S, RTD602334S, RTD601459S, RTD600854S, RTD601766S, RTD600766S, RTD600776S, RTD600778S, RTD601350S, RTD604066S, RTD603107S, RTD603193S, RTD601940S, RTD601998S, RTD602017S, RTD600540S, RTD600542S, RTD601316S, RTD601549S, RTD601372S, RTD601729S, RTD602389S, RTD601733S, RTD602402S, RTD601669S, RTD603963S, RTD603964S, RTD600443S, RTD600793S, RTD600842S, RTD601322S, RTD601406S, RTD601568S, RTD601570S, RTD601581S, RTD601583S, RTD601694S, RTD601756S, RTD602325S, RTD602383S, RTD601508S, RTD601840S, RTD601845S, RTD602799S, RTD603866S, RTD601742S, RTD601743S, RTD601782S, RTD601783S, RTD601785S, RTD601787S, RTD601790S, RTD601833S, RTD601856S, RTD601924S, RTD601951S, RTD601957S, RTD601960S, RTD601968S, RTD601990S, RTD602002S, RTD602014S, RTD602028S, RTD602029S, RTD602030S, RTD602038S, RTD602041S, RTD602068S, RTD602069S, RTD602079S, RTD602086S, RTD602087S, RTD602088S, RTD602089S, RTD602090S, RTD602092S, RTD602099S, RTD602100S, RTD602230S, RTD602309S, RTD602312S, RTD602313S, RTD602340S, RTD602343S, RTD602344S, RTD602345S, RTD602346S, RTD602459S, RTD602460S, RTD602461S, RTD602462S, RTD602470S, RTD601357S, RTD601577S, RTD601630S, RTD601631S, RTD601633S, RTD601797S, RTD601847S, RTD601988S, RTD602142S, RTD604067S, RTD600690S, RTD602453S, RTD604034S, RTD601578S, RTD601832S, RTD602233S, RTD604075S, RTD601258S, RTD601682S, RTD601739S, RTD603694S, RTD601566S, RTD602119S, RTD601796S, RTD601288S, RTD601291S, RTD601293S, RTD601295S, RTD601920S, RTD601921S, RTD601922S, RTD601923S, RTD601926S, RTD601927S, RTD602073S, RTD602074S, RTD602075S, RTD602076S, RTD602431S, RTD602434S, RTD602436S, RTD602443S, RTD602444S, RTD602445S, RTD602447S, RTD602943S, RTD602980S, RTD602981S, RTD602982S, RTD602984S, RTD602985S, RTD602333S, RTD601370S, RTD601371S, RTD601541S, RTD601741S, RTD602044S, RTD603236S, RTD600752S, RTD600404S, RTD601819S, RTD602392S, RTD600508S, RTD601860S, RTD601919S, RTD601969S, RTD604045S, RTD600800S, RTD601627S, RTD601761S, RTD601956S, RTD602879S, RTD602880S, RTD600534S, RTD600767S, RTD601986S, RTD600653S, RTD601657S, RTD600579S, RTD600580S, RTD601458S, RTD600476S, RTD600593S, RTD601343S, RTD602336S, RTD601456S, RTD602251S, RTD600659S, RTD600661S, RTD601721S, RTD603900S, RTD603053S, RTD603899S, RTD603901S, RTD600845S, RTD603188S, RTD600391S, RTD600394S, RTD600430S, RTD601502S, RTD601674S, RTD601749S, RTD600666S, RTD600681S, RTD602354S, RTD602368S, RTD600742S, RTD601321S, RTD601440S, RTD601482S, RTD601664S, RTD601995S, RTD602324S, RTD602366S, RTD602382S, RTD602317S, RTD603206S, RTD600364S, RTD600365S, RTD600440S, RTD600483S, RTD600754S, RTD600816S, RTD600835S, RTD601355S, RTD602020S, RTD602394S, RTD602395S, RTD603737S, RTD600392S, RTD604049S, RTD600373S, RTD602956S, RTD601628S, RTD601744S, RTD601772S, RTD601837S, RTD601839S, RTD601842S, RTD601903S, RTD601911S, RTD601941S, RTD601971S, RTD602040S, RTD602042S, RTD602070S, RTD602071S, RTD602072S, RTD602084S, RTD602105S, RTD602510S, RTD602515S, RTD602516S, RTD602518S, RTD602520S, RTD602521S, RTD602523S, RTD602524S, RTD602525S, RTD602526S, RTD602528S, RTD602529S, RTD602530S, RTD602531S, RTD602532S, RTD602533S, RTD602536S, RTD602537S, RTD602538S, RTD602539S, RTD602542S, RTD602550S, RTD602551S, RTD602553S, RTD602554S, RTD602555S, RTD602557S, RTD602558S, RTD602559S, RTD602560S, RTD602563S, RTD602564S, RTD602565S, RTD602566S, RTD602588S, RTD602589S, RTD602590S, RTD602591S, RTD602595S, RTD602617S, RTD602624S, RTD602625S, RTD602626S, RTD602627S, RTD602628S, RTD602629S, RTD602631S, RTD602632S, RTD602633S, RTD602634S, RTD602635S, RTD602636S, RTD602644S, RTD602651S, RTD602671S, RTD602700S, RTD602701S, RTD602708S, RTD602710S, RTD602711S, RTD602713S, RTD602715S, RTD602716S, RTD602719S, RTD602720S, RTD602721S, RTD602739S, RTD602777S, RTD602781S, RTD602838S, RTD602883S, RTD602887S, RTD602888S, RTD602889S, RTD602890S, RTD602891S, RTD602892S, RTD602900S, RTD602902S, RTD602912S, RTD602914S, RTD602915S, RTD602916S, RTD602917S, RTD602921S, RTD602923S, RTD602925S, RTD602928S, RTD602929S, RTD602930S, RTD602954S, RTD602955S, RTD602971S, RTD602976S, RTD602977S, RTD602978S, RTD602983S, RTD602986S, RTD603004S, RTD603005S, RTD603006S, RTD603010S, RTD603068S, RTD603075S, RTD603078S, RTD603089S, RTD603098S, RTD603116S, RTD603149S, RTD603151S, RTD603152S, RTD603154S, RTD603155S, RTD603157S, RTD603169S, RTD603170S, RTD603174S, RTD603175S, RTD603176S, RTD603177S, RTD603181S, RTD603185S, RTD603186S, RTD603192S, RTD603201S, RTD603202S, RTD603237S, RTD603238S, RTD603239S, RTD603240S, RTD603241S, RTD603242S, RTD603244S, RTD603245S, RTD603246S, RTD603249S, RTD603250S, RTD603251S, RTD603255S, RTD603257S, RTD603258S, RTD603260S, RTD603261S, RTD603262S, RTD603272S, RTD603277S, RTD603278S, RTD603308S, RTD603336S, RTD603358S, RTD603718S, RTD603776S, RTD603782S, RTD603786S, RTD603855S, RTD603935S, RTD603939S, RTD603940S, RTD603948S, RTD603996S, RTD602511S, RTD602567S, RTD602568S, RTD602569S, RTD602571S, RTD602573S, RTD602574S, RTD602576S, RTD602577S, RTD602579S, RTD602580S, RTD602581S, RTD602582S, RTD602583S, RTD602584S, RTD602585S, RTD602637S, RTD602638S, RTD602639S, RTD602640S, RTD602641S, RTD602642S, RTD602643S, RTD602645S, RTD602646S, RTD602647S, RTD602648S, RTD602649S, RTD602650S, RTD602652S, RTD602653S, RTD602654S, RTD602655S, RTD602656S, RTD602657S, RTD602658S, RTD602659S, RTD602661S, RTD602663S, RTD602668S, RTD602674S, RTD602676S, RTD602677S, RTD602679S, RTD602680S, RTD602681S, RTD602684S, RTD602686S, RTD602687S, RTD602688S, RTD602690S, RTD602692S, RTD602693S, RTD602694S, RTD602695S, RTD602696S, RTD602697S, RTD602698S, RTD602699S, RTD602702S, RTD602703S, RTD602704S, RTD602705S, RTD602706S, RTD602707S, RTD602709S, RTD602778S, RTD602779S, RTD602782S, RTD602785S, RTD602786S, RTD602787S, RTD602788S, RTD602789S, RTD602790S, RTD602792S, RTD602793S, RTD602794S, RTD602796S, RTD602797S, RTD602798S, RTD602800S, RTD602801S, RTD602802S, RTD602803S, RTD602804S, RTD602805S, RTD602806S, RTD602807S, RTD602808S, RTD602809S, RTD602810S, RTD602811S, RTD602812S, RTD602813S, RTD602814S, RTD602815S, RTD602816S, RTD602817S, RTD602818S, RTD602819S, RTD602820S, RTD602821S, RTD602822S, RTD602823S, RTD602824S, RTD602825S, RTD602827S, RTD602829S, RTD602830S, RTD602833S, RTD602834S, RTD602835S, RTD602836S, RTD602839S, RTD602840S, RTD602841S, RTD602843S, RTD602844S, RTD602854S, RTD602855S, RTD602856S, RTD602857S, RTD602858S, RTD602859S, RTD602860S, RTD602861S, RTD602862S, RTD602863S, RTD602864S, RTD602865S, RTD602866S, RTD602867S, RTD602869S, RTD602870S, RTD602871S, RTD602872S, RTD602873S, RTD602874S, RTD602876S, RTD602877S, RTD602878S, RTD602893S, RTD602895S, RTD602897S, RTD602899S, RTD602905S, RTD602906S, RTD602907S, RTD602908S, RTD602909S, RTD602911S, RTD602922S, RTD602940S, RTD602941S, RTD602944S, RTD602945S, RTD602946S, RTD602947S, RTD602948S, RTD602949S, RTD602950S, RTD602951S, RTD602952S, RTD602953S, RTD602959S, RTD602960S, RTD602961S, RTD602962S, RTD602963S, RTD602964S, RTD602965S, RTD602966S, RTD602967S, RTD602968S, RTD602969S, RTD602972S, RTD602973S, RTD602975S, RTD602987S, RTD602988S, RTD602990S, RTD602991S, RTD602992S, RTD602993S, RTD602994S, RTD602997S, RTD602998S, RTD602999S, RTD603000S, RTD603001S, RTD603002S, RTD603003S, RTD603012S, RTD603013S, RTD603014S, RTD603016S, RTD603018S, RTD603032S, RTD603033S, RTD603042S, RTD603043S, RTD603045S, RTD603047S, RTD603048S, RTD603051S, RTD603052S, RTD603054S, RTD603057S, RTD603066S, RTD603067S, RTD603071S, RTD603072S, RTD603073S, RTD603074S, RTD603082S, RTD603096S, RTD603099S, RTD603118S, RTD603121S, RTD603122S, RTD603123S, RTD603126S, RTD603130S, RTD603134S, RTD603139S, RTD603140S, RTD603141S, RTD603142S, RTD603143S, RTD603144S, RTD603146S, RTD603164S, RTD603165S, RTD603168S, RTD603178S, RTD603183S, RTD603194S, RTD603213S, RTD603226S, RTD603228S, RTD603230S, RTD603231S, RTD603259S, RTD603293S, RTD603294S, RTD603295S, RTD603296S, RTD603297S, RTD603299S, RTD603300S, RTD603301S, RTD603302S, RTD603303S, RTD603304S, RTD603306S, RTD603307S, RTD603309S, RTD603310S, RTD603311S, RTD603312S, RTD603313S, RTD603314S, RTD603316S, RTD603317S, RTD603319S, RTD603322S, RTD603323S, RTD603324S, RTD603325S, RTD603331S, RTD603332S, RTD603343S, RTD603344S, RTD603347S, RTD603349S, RTD603353S, RTD603354S, RTD603355S, RTD603356S, RTD603360S, RTD603361S, RTD603364S, RTD603376S, RTD603379S, RTD603386S, RTD603390S, RTD603393S, RTD603395S, RTD603396S, RTD603397S, RTD603398S, RTD603399S, RTD603400S, RTD603401S, RTD603402S, RTD603405S, RTD603406S, RTD603407S, RTD603408S, RTD603412S, RTD603413S, RTD603414S, RTD603415S, RTD603416S, RTD603417S, RTD603418S, RTD603420S, RTD603421S, RTD603424S, RTD603648S, RTD603649S, RTD603696S, RTD603700S, RTD603704S, RTD603710S, RTD603713S, RTD603736S, RTD603738S, RTD603742S, RTD603743S, RTD603744S, RTD603746S, RTD603747S, RTD603748S, RTD603750S, RTD603760S, RTD603768S, RTD603769S, RTD603770S, RTD603775S, RTD603790S, RTD603799S, RTD603800S, RTD603817S, RTD603831S, RTD603835S, RTD603840S, RTD603842S, RTD603843S, RTD603852S, RTD603856S, RTD603860S, RTD603861S, RTD603874S, RTD603914S, RTD603921S, RTD603924S, RTD603926S, RTD603960S, RTD603971S, RTD603984S, RTD603993S, RTD604016S, RTD601763S, RTD602939S, RTD604052S, RTD600421S, RTD601485S, RTD600857S, RTD601483S, RTD601676S, RTD603198S, RTD600369S, RTD601827S, RTD601928S, RTD602995S, RTD601678S, RTD601679S, RTD601681S, RTD601439S, RTD600846S, RTD600414S, RTD603342S, RTD603919S, RTD600753S, RTD601821S, RTD602024S, RTD603654S, RTD600798S, RTD601490S, RTD602036S, RTD603690S, RTD600787S, RTD601996S, RTD601655S, RTD602331S, RTD603328S, RTD603726S, RTD601358S, RTD600368S, RTD600834S, RTD601368S, RTD601983S, RTD601354S, RTD600428S, RTD601829S, RTD601737S, RTD603229S, RTD603233S, RTD601809S, RTD602236S, RTD600810S, RTD601668S, RTD601706S, RTD601804S, RTD603184S, RTD604041S, RTD600360S, RTD600366S, RTD600376S, RTD600395S, RTD600401S, RTD600490S, RTD600705S, RTD600740S, RTD600768S, RTD600770S, RTD600782S, RTD600813S, RTD601351S, RTD601452S, RTD601561S, RTD601650S, RTD601734S, RTD601735S, RTD601812S, RTD601820S, RTD601961S, RTD602137S, RTD602245S, RTD600831S, RTD601324S, RTD601469S, RTD601939S, RTD600610S, RTD601366S, RTD601691S, RTD601699S, RTD602004S, RTD601617S, RTD601705S, RTD603965S, RTD600727S, RTD601555S, RTD603645S, RTD603646S, RTD603636S, RTD603644S, RTD603871S, RTD604058S, RTD601724S, RTD603715S, RTD601727S, RTD600510S, RTD600765S, RTD600827S, RTD601747S, RTD603858S, RTD603859S, RTD600431S, RTD600436S, RTD603698S, RTD601383S, RTD601673S, RTD601476S, RTD602302S, RTD602003S, RTD603195S, RTD600682S, RTD601731S, RTD601765S, RTD600424S, RTD601663S, RTD602001S, RTD600594S, RTD601424S, RTD601993S, RTD602241S, RTD601689S, RTD602021S, RTD601725S, RTD601462S, RTD602691S, RTD601929S, RTD603865S, RTD600479S, RTD600645S, RTD600737S, RTD601707S, RTD600731S, RTD601468S, RTD602018S, RTD601759S, RTD601598S, RTD601506S, RTD601848S, RTD600732S, RTD600847S, RTD601712S, RTD601803S, RTD603999S, RTD602996S, RTD604008S, RTD601380S, RTD603223S, RTD603224S, RTD600429S, RTD600444S, RTD600482S, RTD600488S, RTD600521S, RTD600573S, RTD600608S, RTD600699S, RTD600715S, RTD600780S, RTD601338S, RTD601365S, RTD601412S, RTD601565S, RTD601596S, RTD601597S, RTD601835S, RTD601994S, RTD602335S, RTD602077S, RTD602083S, RTD603234S, RTD603235S, RTD603252S, RTD600851S, RTD600852S, RTD601474S, RTD601478S, RTD601776S, RTD601777S, RTD601693S, RTD600372S, RTD600374S, RTD600495S, RTD601391S, RTD601402S, RTD601773S, RTD601784S, RTD601816S, RTD602117S, RTD601437S, RTD600367S, RTD600388S, RTD600432S, RTD600496S, RTD600684S, RTD600764S, RTD601313S, RTD601442S, RTD601675S, RTD601805S, RTD601987S, RTD602047S, RTD602112S, RTD602152S, RTD602332S, RTD603211S, RTD603426S, RTD603427S, RTD603428S, RTD604038S, RTD604039S, RTD604040S, RTD602006S, RTD601571S, RTD604080S, RTD600588S, RTD601726S, RTD601703S, RTD600355S, RTD600641S, RTD601587S, RTD602005S, RTD603124S, RTD601698S, RTD600596S, RTD602299S, RTD600672S, RTD604010S, RTD601972S, RTD604065S, RTD603870S, RTD601685S, RTD600506S, RTD600499S, RTD600660S, RTD600670S, RTD600696S, RTD600792S, RTD601405S, RTD601416S, RTD601704S, RTD601984S, RTD601992S, RTD602305S, RTD602722S, RTD601397S, RTD601404S, RTD601418S, RTD601430S, RTD601461S, RTD601521S, RTD602868S, RTD601740S, RTD602115S, RTD603546S, RTD603547S, RTD603548S, RTD603549S, RTD603550S, RTD603555S, RTD603563S, RTD603564S, RTD603565S, RTD603566S, RTD603567S, RTD603573S, RTD603574S, RTD603575S, RTD603576S, RTD603578S, RTD600685S, RTD603429S, RTD603431S, RTD603435S, RTD603436S, RTD603439S, RTD603440S, RTD603442S, RTD603495S, RTD603496S, RTD603497S, RTD603498S, RTD603499S, RTD603500S, RTD603501S, RTD602556S, RTD602666S, RTD602669S, RTD602932S, RTD602933S, RTD602934S, RTD602935S, RTD602936S, RTD602937S, RTD603263S, RTD603265S, RTD603266S, RTD603268S, RTD603269S, RTD603270S, RTD603511S, RTD603512S, RTD603513S, RTD603514S, RTD603515S, RTD603516S, RTD603720S, RTD603721S, RTD603722S, RTD602979S, RTD603274S, RTD603375S, RTD601455S, RTD603214S, RTD603215S, RTD603216S, RTD603217S, RTD603218S, RTD603219S, RTD603220S, RTD603221S, RTD603222S, RTD602023S, RTD602026S, RTD602037S, RTD603019S, RTD603024S, RTD603147S, RTD603148S, RTD603150S, RTD601732S, RTD601800S, RTD603196S, RTD603197S, RTD601339S, RTD601446S, RTD601500S, RTD601774S, RTD601799S, RTD602219S, RTD602220S, RTD602222S, RTD602406S, RTD602407S, RTD603011S, RTD603275S, RTD603276S, RTD603280S, RTD603532S, RTD603533S, RTD603534S, RTD603535S, RTD603536S, RTD603537S, RTD603538S, RTD603539S, RTD603540S, RTD603541S, RTD603542S, RTD603543S, RTD603544S, RTD600763S, RTD601822S, RTD601962S, RTD601626S, RTD601701S, RTD601273S, RTD600853S, RTD601652S, RTD600358S, RTD600452S, RTD601352S, RTD601353S, RTD601687S, RTD600781S, RTD601718S, RTD600447S, RTD601662S, RTD603422S, RTD601817S, RTD601825S, RTD600465S, RTD600843S, RTD602114S, RTD603957S, RTD604024S, RTD600473S, RTD600518S, RTD601710S, RTD601828S, RTD602011S, RTD600749S, RTD602240S, RTD602338S, RTD604053S, RTD601487S, RTD601574S, RTD600565S, RTD601417S, RTD601700S, RTD600475S, RTD604000S, RTD600531S, RTD600643S, RTD601332S, RTD601376S, RTD601413S, RTD602124S, RTD601764S, RTD601974S, RTD600824S, RTD601491S, RTD600605S, RTD600706S, RTD600746S, RTD601449S, RTD601686S, RTD601697S, RTD601720S, RTD601831S, RTD601736S, RTD600599S, RTD600462S, RTD600463S, RTD600592S, RTD600630S, RTD600631S, RTD600750S, RTD600804S, RTD601342S, RTD601531S, RTD601672S, RTD601793S, RTD601795S, RTD601328S, RTD601717S, RTD602330S, RTD602022S, RTD600439S, RTD600497S, RTD602148S, RTD602263S, RTD603581S, RTD603582S, RTD603583S, RTD603584S, RTD603629S, RTD603631S, RTD603634S, RTD600649S, RTD600549S, RTD603517S, RTD603518S, RTD603519S, RTD603520S, RTD603521S, RTD603522S, RTD603523S, RTD603524S, RTD603525S, RTD603526S, RTD603527S, RTD603528S, RTD603529S, RTD603530S, RTD601427S, RTD603503S, RTD603505S, RTD603506S, RTD603507S, RTD603508S, RTD603509S, RTD603510S, RTD603281S, RTD603282S, RTD602342S, RTD601980S, RTD601981S, RTD602123S, RTD603187S, RTD603189S, RTD603190S, RTD603247S, RTD603248S, RTD603256S, RTD603821S, RTD603825S, RTD602384S, RTD602385S, RTD602386S, RTD602545S, RTD602547S, RTD603283S, RTD603284S, RTD603285S, RTD603287S, RTD603288S, RTD603289S, RTD601611S, RTD602025S, RTD601299S, RTD601300S, RTD601360S, RTD601361S, RTD601362S, RTD601419S, RTD601428S, RTD601453S, RTD601559S, RTD601621S, RTD601629S, RTD601634S, RTD601637S, RTD601639S, RTD601643S, RTD601645S, RTD601646S, RTD601647S, RTD601648S, RTD601653S, RTD601656S, RTD601658S, RTD601677S, RTD601754S, RTD601755S, RTD601768S, RTD601769S, RTD601770S, RTD601771S, RTD601826S, RTD601944S, RTD601947S, RTD601948S, RTD601949S, RTD601950S, RTD601952S, RTD601953S, RTD601954S, RTD601958S, RTD601959S, RTD602016S, RTD602045S, RTD602080S, RTD602081S, RTD602082S, RTD602085S, RTD602101S, RTD602103S, RTD602106S, RTD602107S, RTD602108S, RTD602109S, RTD602110S, RTD602223S, RTD602224S, RTD602225S, RTD602226S, RTD602349S, RTD602350S, RTD602351S, RTD602352S, RTD602353S, RTD602412S, RTD602413S, RTD602423S, RTD602424S, RTD602471S, RTD602485S, RTD602489S, RTD602630S, RTD602670S, RTD602672S, RTD602673S, RTD602712S, RTD602714S, RTD602717S, RTD602718S, RTD602881S, RTD602882S, RTD602884S, RTD602886S, RTD602901S, RTD602919S, RTD602920S, RTD602924S, RTD602926S, RTD602931S, RTD603208S, RTD603209S, RTD603337S, RTD603338S, RTD603339S, RTD603340S, RTD603365S, RTD603366S, RTD603369S, RTD603370S, RTD603977S, RTD603978S, RTD600584S, RTD601434S, RTD601533S, RTD601640S, RTD601970S, RTD602039S, RTD602310S, RTD602311S, RTD602341S, RTD602903S, RTD602904S, RTD602918S, RTD601834S, RTD603998S, RTD603090S, RTD603091S, RTD603889S, RTD600459S, RTD600474S, RTD601642S, RTD601757S, RTD601758S; GTIN 00763000178123, Lot Serial Numbers: RTD601030S, RTD601582S, RTD603556S, RTD603330S, RTD603661S, RTD603443S, RTD603664S, RTD604305S, RTD604222S, RTD603092S, RTD603933S, RTD603136S, RTD603711S, RTD603725S, RTD603732S, RTD603755S, RTD603756S, RTD603762S, RTD603763S, RTD603765S, RTD602188S, RTD602731S, RTD602475S, RTD600343S, RTD603115S, RTD600595S, RTD601178S, RTD603132S, RTD601066S, RTD602144S, RTD600441S, RTD601205S, RTD601624S, RTD602163S, RTD600347S, RTD603504S, RTD600602S, RTD601867S, RTD602483S, RTD603114S, RTD600337S, RTD601256S, RTD602760S, RTD602187S, RTD600342S, RTD600553S, RTD602441S, RTD600245S, RTD603050S, RTD603023S, RTD601388S, RTD603131S, RTD601378S, RTD603031S, RTD601879S, RTD603039S, RTD600858S, RTD601033S, RTD602171S, RTD602433S, RTD601031S, RTD601189S, RTD601509S, RTD602156S, RTD603383S, RTD603953S, RTD601103S, RTD602615S, RTD603363S, RTD603382S, RTD603639S, RTD601262S, RTD601593S, RTD602373S, RTD602738S, RTD603065S, RTD601588S, RTD600985S, RTD603659S, RTD600224S, RTD600227S, RTD600231S, RTD600232S, RTD600247S, RTD600446S, RTD600957S, RTD600968S, RTD601233S, RTD601107S, RTD601386S, RTD601864S, RTD601379S, RTD602131S, RTD602136S, RTD602189S, RTD602611S, RTD602612S, RTD603028S, RTD603029S, RTD604260S, RTD601654S, RTD601012S, RTD601190S, RTD601276S, RTD601217S, RTD602742S, RTD600238S, RTD600340S, RTD600349S, RTD600350S, RTD602741S, RTD603886S, RTD600919S, RTD601015S, RTD601022S, RTD603026S, RTD603027S, RTD602143S, RTD602509S, RTD600956S, RTD603030S, RTD600338S, RTD601137S, RTD601152S, RTD601176S, RTD601179S, RTD601198S, RTD601240S, RTD601387S, RTD601567S, RTD601865S, RTD601874S, RTD601898S, RTD602128S, RTD602165S, RTD602167S, RTD602170S, RTD602186S, RTD602362S, RTD602363S, RTD602370S, RTD602513S, RTD602733S, RTD602734S, RTD602735S, RTD602898S, RTD603191S, RTD600230S, RTD601564S, RTD602372S, RTD602176S, RTD602178S, RTD603958S, RTD604027S, RTD600344S, RTD602549S, RTD603635S, RTD600525S, RTD600937S, RTD601194S, RTD601889S, RTD602586S, RTD603385S, RTD602168S, RTD603117S, RTD602141S, RTD601880S, RTD601083S, RTD601223S, RTD603104S, RTD601236S, RTD601237S, RTD601609S, RTD602477S, RTD603166S, RTD603113S, RTD600958S, RTD601863S, RTD602153S, RTD604238S, RTD600946S, RTD602374S, RTD601576S, RTD600377S, RTD601183S, RTD600249S, RTD600975S, RTD601251S, RTD601278S, RTD601280S, RTD601390S, RTD601608S, RTD601906S, RTD601909S, RTD603162S, RTD604155S, RTD601216S, RTD602135S, RTD604202S, RTD600221S, RTD601271S, RTD601595S, RTD602467S, RTD603642S, RTD601242S, RTD601266S, RTD601454S, RTD602126S, RTD602725S, RTD602726S, RTD602174S, RTD600978S, RTD601260S, RTD602376S, RTD602122S, RTD600568S, RTD603022S, RTD600219S, RTD602754S, RTD601301S, RTD601234S, RTD603021S, RTD601470S, RTD601253S, RTD602365S, RTD602478S, RTD601069S, RTD601201S, RTD601897S, RTD601243S, RTD601007S, RTD600471S, RTD601027S, RTD601187S, RTD601277S, RTD601085S, RTD601087S, RTD601214S, RTD601226S, RTD603009S, RTD601020S, RTD601908S, RTD603630S, RTD601082S, RTD602758S, RTD603652S, RTD601075S, RTD602736S, RTD603025S, RTD603658S, RTD603683S, RTD600938S, RTD601910S, RTD601009S, RTD601010S, RTD601024S, RTD602162S, RTD601197S, RTD601203S, RTD601398S, RTD602747S, RTD603692S, RTD600555S, RTD602599S, RTD601248S, RTD601477S, RTD602104S, RTD602129S, RTD602183S, RTD603791S, RTD600514S, RTD600345S, RTD600554S, RTD600947S, RTD600951S, RTD601231S, RTD601377S, RTD601385S, RTD601886S, RTD601235S, RTD601473S, RTD601873S, RTD601884S, RTD601222S, RTD601373S, RTD601191S, RTD600929S, RTD600992S, RTD602369S, RTD602737S, RTD601215S, RTD602098S, RTD603112S, RTD600223S, RTD600601S, RTD600953S, RTD601206S, RTD601209S, RTD601239S, RTD601279S, RTD601457S, RTD602094S, RTD601211S, RTD601265S, RTD600467S, RTD601048S, RTD603719S, RTD600246S, RTD600339S, RTD600942S, RTD601272S, RTD601275S, RTD602775S, RTD601590S, RTD600984S, RTD601888S, RTD601900S, RTD603035S, RTD603036S, RTD601902S, RTD600242S, RTD600243S, RTD600244S, RTD600526S, RTD600551S, RTD601004S, RTD601005S, RTD601220S, RTD601475S, RTD600964S, RTD601522S, RTD602161S, RTD602463S, RTD602464S, RTD602472S, RTD602473S, RTD602474S, RTD602765S, RTD601023S, RTD601034S, RTD601904S, RTD600341S, RTD601885S, RTD602751S, RTD603173S, RTD603691S, RTD600936S, RTD601244S, RTD601394S, RTD600589S, RTD602546S, RTD601175S, RTD602127S, RTD602169S, RTD602730S, RTD602772S, RTD603199S, RTD603676S, RTD601270S, RTD600613S, RTD600403S, RTD600352S, RTD603087S, RTD601006S, RTD600922S, RTD600940S, RTD600966S, RTD600983S, RTD601046S, RTD601047S, RTD601547S, RTD602771S, RTD600932S, RTD600971S, RTD601042S, RTD602769S, RTD603432S, RTD600970S, RTD601329S, RTD601330S, RTD601553S, RTD601557S, RTD601548S, RTD601200S, RTD601359S, RTD601029S, RTD600986S, RTD601081S, RTD601545S, RTD601051S, RTD601436S, RTD603374S, RTD601054S, RTD600950S, RTD600960S, RTD601049S, RTD603433S, RTD603434S, RTD600920S, RTD601538S, RTD602616S, RTD602619S, RTD600923S, RTD600924S, RTD600934S, RTD601556S, RTD602415S, RTD600981S, RTD601050S, RTD603392S, RTD600954S, RTD601002S, RTD601429S, RTD601008S, RTD601348S, RTD600967S, RTD601319S, RTD601043S, RTD601044S, RTD602767S, RTD601061S, RTD601554S, RTD603279S, RTD601056S, RTD601014S, RTD601180S, RTD600927S, RTD600928S, RTD600943S, RTD600952S, RTD601327S, RTD603326S, RTD602623S, RTD603321S, RTD603341S, RTD601204S, RTD601210S, RTD602605S, RTD601393S, RTD601199S, RTD603352S, RTD600939S, RTD600994S, RTD601086S, RTD601363S, RTD601426S, RTD601431S, RTD601539S, RTD602618S, RTD602606S, RTD601325S, RTD601315S, RTD601058S, RTD601208S, RTD602620S, RTD603377S, RTD601068S, RTD601072S, RTD601077S, RTD601326S, RTD603381S, RTD603384S, RTD601070S, RTD601071S, RTD603346S, RTD603372S, RTD602621S, RTD603351S, RTD601185S, RTD602724S, RTD600945S, RTD600963S, RTD601055S, RTD600931S, RTD601186S, RTD603334S, RTD601550S, RTD601283S, RTD601572S, RTD603625S, RTD600409S, RTD602746S, RTD600604S, RTD601182S, RTD602149S, RTD601053S, RTD601450S, RTD601255S, RTD601401S, RTD602723S, RTD603419S, RTD602456S, RTD600248S, RTD601076S, RTD603329S, RTD601003S, RTD601032S, RTD601040S, RTD601281S, RTD601585S, RTD601212S, RTD603438S, RTD601912S, RTD602512S, RTD602552S, RTD602610S, RTD602613S, RTD602614S, RTD602138S, RTD601331S, RTD600965S, RTD601480S, RTD601890S, RTD602752S, RTD602763S, RTD601282S, RTD603695S, RTD601592S, RTD600423S, RTD602364S, RTD604160S, RTD602378S, RTD602421S, RTD602430S, RTD602438S, RTD602479S, RTD602487S, RTD602587S, RTD602601S, RTD602622S, RTD602675S, RTD602727S, RTD602728S, RTD602729S, RTD602732S, RTD602755S, RTD602756S, RTD602770S, RTD602773S, RTD602774S, RTD602885S, RTD603008S, RTD603037S, RTD603063S, RTD603080S, RTD603081S, RTD603083S, RTD603093S, RTD603103S, RTD603156S, RTD603159S, RTD603161S, RTD603167S, RTD603171S, RTD603254S, RTD603273S, RTD603286S, RTD603290S, RTD603291S, RTD603335S, RTD603368S, RTD603373S, RTD603387S, RTD603388S, RTD603437S, RTD603531S, RTD603557S, RTD603558S, RTD603560S, RTD603562S, RTD603571S, RTD603626S, RTD603628S, RTD603632S, RTD603643S, RTD603651S, RTD603656S, RTD603665S, RTD603668S, RTD603677S, RTD603681S, RTD603682S, RTD603684S, RTD603685S, RTD603687S, RTD603705S, RTD603706S, RTD603707S, RTD603708S, RTD603709S, RTD603712S, RTD603727S, RTD603729S, RTD603734S, RTD603752S, RTD603759S, RTD603761S, RTD603767S, RTD603771S, RTD603773S, RTD603774S, RTD603777S, RTD603778S, RTD603779S, RTD603780S, RTD603781S, RTD603788S, RTD603793S, RTD603830S, RTD603833S, RTD603839S, RTD603845S, RTD603846S, RTD603850S, RTD603864S, RTD603868S, RTD603878S, RTD603879S, RTD603880S, RTD603881S, RTD603930S, RTD603937S, RTD603938S, RTD604025S, RTD604162S, RTD604167S, RTD604186S, RTD604215S, RTD604221S, RTD604228S, RTD604261S, RTD604262S, RTD604264S, RTD604275S, RTD604319S, RTD602057S, RTD602102S, RTD602160S, RTD602181S, RTD602185S, RTD602134S, RTD602145S; GTIN 00763000402228, Lot Serial Numbers: RTD600624S, RTD602315S, RTD602593S, RTD602541S, RTD602308S, RTD602408S, RTD600989S, RTD601166S, RTD602496S, RTD602486S, RTD602271S, RTD602439S, RTD601112S, RTD602660S, RTD602469S, RTD603038S, RTD601606S, RTD602492S, RTD601150S, RTD602266S, RTD601887S, RTD602495S, RTD602125S, RTD601165S, RTD602314S, RTD601115S, RTD601131S, RTD602179S, RTD602227S, RTD602259S, RTD602260S, RTD602270S, RTD601623S, RTD602602S, RTD600993S, RTD601122S, RTD603545S, RTD602481S, RTD601625S, RTD602231S, RTD601124S, RTD602154S, RTD602155S, RTD600925S, RTD602493S, RTD601121S, RTD601100S, RTD601113S, RTD602596S, RTD601146S, RTD600618S, RTD601172S, RTD601129S, RTD603568S, RTD602494S, RTD603766S, RTD601102S, RTD600997S, RTD602875S, RTD601882S, RTD602244S, RTD602449S, RTD601130S, RTD601607S, RTD600614S, RTD601869S, RTD602265S, RTD601125S, RTD601139S, RTD601145S, RTD601171S, RTD602159S, RTD602256S, RTD602425S, RTD602428S, RTD602429S, RTD602578S, RTD600559S, RTD600988S, RTD600987S, RTD601114S, RTD601158S, RTD602572S, RTD602243S, RTD603271S, RTD602420S, RTD602254S, RTD602422S, RTD601132S, RTD602246S, RTD601389S, RTD600627S, RTD602228S, RTD603570S, RTD601118S, RTD600622S, RTD601135S, RTD600996S, RTD601140S, RTD600615S, RTD602570S, RTD601620S, RTD601196S, RTD601866S, RTD602257S, RTD602488S, RTD602608S, RTD601161S, RTD602468S, RTD602592S, RTD600566S, RTD602534S, RTD601157S, RTD600574S, RTD601154S, RTD602517S, RTD600926S, RTD601117S, RTD601560S, RTD602466S, RTD600991S, RTD602238S, RTD602594S, RTD601181S, RTD601138S, RTD601148S, RTD603787S, RTD601065S, RTD601174S, RTD601119S, RTD602275S, RTD601195S, RTD603702S, RTD603569S, RTD601892S, RTD601128S, RTD601162S, RTD601153S, RTD601160S, RTD601141S, RTD601080S, RTD601104S, RTD601164S, RTD603559S, RTD601528S, RTD602262S, RTD602252S, RTD602172S, RTD602264S, RTD601144S, RTD601155S, RTD601173S, RTD600995S, RTD601111S, RTD601527S, RTD601513S.RTD601169S, RTD601167S, RTD601618S, RTD600626S, RTD602235S, RTD601883S, RTD601537S, RTD601871S, RTD602164S, RTD600962S, RTD600779S, RTD603179S, RTD603813S
• 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: 2669 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; PMAs with Product Code = NIK