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U.S. Department of Health and Human Services

Class 1 Device Recall medtronic

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  Class 1 Device Recall medtronic see related information
Date Initiated by Firm May 10, 2023
Date Posted June 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-1719-2023
Recall Event ID 92328
PMA Number P980016S653 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators

Code Information GTIN 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS602880S, CWS602742S, CWS602559S, CWS602607S, CWS602433S, CWS602957S, CWS601056S, CWS601348S, CWS601807S, CWS602219S, CWS602422S, CWS602474S, CWS601519S, CWS601425S, CWS601296S, CWS602918S, CWS600483S, CWS600490S, CWS600494S, CWS600607S, CWS600960S, CWS601001S, CWS601199S, CWS601460S, CWS601594S, CWS601704S, CWS601713S, CWS601790S, CWS600422S, CWS600502S, CWS600125S, CWS600132S, CWS600342S, CWS600571S, CWS601791S, CWS600172S, CWS600318S, CWS600423S, CWS600453S, CWS600464S, CWS600686S, CWS601122S, CWS601155S, CWS601445S, CWS601981S, CWS601465S, CWS601628S, CWS600445S, CWS602676S, CWS600945S, CWS600142S, CWS600147S, CWS600178S, CWS600551S, CWS600557S, CWS600770S, CWS600996S, CWS601094S, CWS601323S, CWS601966S, CWS602181S, CWS602556S, CWS602618S, CWS602879S, CWS601541S, CWS601542S, CWS601203S, CWS601374S, CWS602139S, CWS600458S, CWS600102S, CWS600781S, CWS600759S, CWS600764S, CWS600765S, CWS600805S, CWS600806S, CWS600807S, CWS601024S, CWS601111S, CWS601201S, CWS601718S, CWS601979S, CWS602753S, CWS600731S, CWS601304S, CWS601780S, CWS602108S, CWS602214S, CWS601240S, CWS602411S, CWS602889S, CWS600108S, CWS601150S, CWS602620S, CWS601627S, CWS600523S, CWS600244S, CWS600631S, CWS600234S, CWS600315S, CWS600412S, CWS600432S, CWS600699S, CWS600804S, CWS601098S, CWS601210S, CWS601219S, CWS601223S, CWS601225S, CWS601309S, CWS601313S, CWS601431S, CWS601434S, CWS601723S, CWS601904S, CWS602455S, CWS602456S, CWS602749S, CWS600498S, CWS600782S, CWS601329S, CWS600180S, CWS600503S, CWS601216S, CWS601586S, CWS601971S, CWS602609S, CWS602881S, CWS600255S, CWS600884S, CWS600268S, CWS600309S, CWS600767S, CWS600987S, CWS601050S, CWS601310S, CWS601314S, CWS601609S, CWS602121S, CWS601543S, CWS601593S, CWS602105S, CWS601562S, CWS601563S, CWS602067S, CWS601744S, CWS600344S, CWS601389S, CWS601393S, CWS601433S, CWS601438S, CWS601442S, CWS601447S, CWS601510S, CWS601571S, CWS601607S, CWS601685S, CWS601686S, CWS601741S, CWS601756S, CWS601862S, CWS601869S, CWS602485S, CWS600355S, CWS601071S, CWS600314S, CWS600594S, CWS600602S, CWS600155S, CWS602631S, CWS600164S, CWS600149S, CWS600179S, CWS600187S, CWS600348S, CWS600434S, CWS600463S, CWS600521S, CWS600934S, CWS601020S, CWS601059S, CWS601232S, CWS601630S, CWS601814S, CWS601838S, CWS602126S, CWS600186S, CWS600222S, CWS600266S, CWS600269S, CWS600306S, CWS600363S, CWS600541S, CWS600542S, CWS600543S, CWS600876S, CWS600882S, CWS600883S, CWS600889S, CWS600951S, CWS600993S, CWS601087S, CWS601175S, CWS601324S, CWS601330S, CWS601411S, CWS601413S, CWS601712S, CWS601811S, CWS602058S, CWS602568S, CWS602835S, CWS602836S, CWS600260S, CWS600400S, CWS600684S, CWS600787S, CWS600912S, CWS601058S, CWS601085S, CWS601161S, CWS601247S, CWS601253S, CWS601346S, CWS601599S, CWS601709S, CWS601879S, CWS601925S, CWS601935S, CWS602432S, CWS602445S, CWS600140S, CWS600185S, CWS600283S, CWS600720S, CWS600812S, CWS600855S, CWS601043S, CWS601338S, CWS601613S, CWS601732S, CWS602001S, CWS602005S, CWS602006S, CWS602120S, CWS602384S, CWS602884S, CWS601388S, CWS600712S, CWS600955S, CWS601637S, CWS600933S, CWS600228S, CWS600741S, CWS600982S, CWS601037S, CWS602447S, CWS600430S, CWS602864S, CWS602865S, CWS602866S, CWS602870S, CWS602960S, CWS602961S, CWS602962S, CWS601483S, CWS601487S, CWS601717S, CWS602608S, CWS602630S, CWS602888S, CWS601153S, CWS601156S, CWS601385S, CWS601080S, CWS600461S, CWS600510S, CWS600524S, CWS600702S, CWS601072S, CWS601824S, CWS600909S, CWS601354S, CWS602837S, CWS600725S, CWS600991S, CWS601466S, CWS601302S, CWS602106S, CWS601531S, CWS601614S, CWS600123S, CWS600426S, CWS600978S, CWS601962S, CWS600439S, CWS600785S, CWS600106S, CWS600174S, CWS602109S, CWS602486S, CWS600418S, CWS600451S, CWS600721S, CWS600783S, CWS601157S, CWS601222S, CWS601228S, CWS601252S, CWS601279S, CWS601305S, CWS601379S, CWS601397S, CWS601439S, CWS602077S, CWS602213S, CWS602425S, CWS602493S, CWS602531S, CWS600886S, CWS600888S, CWS601527S, CWS602301S, CWS601288S, CWS602171S, CWS600719S, CWS600158S, CWS600471S, CWS600832S, CWS601115S, CWS601164S, CWS600103S, CWS600302S, CWS600312S, CWS600475S, CWS600526S, CWS600232S, CWS601498S, CWS602013S, CWS600761S, CWS601493S, CWS602117S, CWS602414S, CWS600773S, CWS600774S, CWS601373S, CWS600539S, CWS601202S, CWS601903S, CWS600171S, CWS601554S, CWS602675S, CWS600177S, CWS600692S, CWS601591S, CWS601174S, CWS601198S, CWS602062S, CWS600603S, CWS600986S, CWS601088S, CWS601109S, CWS601437S, CWS602480S, CWS601355S, CWS601496S, CWS602610S, CWS600834S, CWS601014S, CWS601166S, CWS600495S, CWS602079S, CWS601132S, CWS601140S, CWS601363S, CWS600766S, CWS600971S, CWS601019S, CWS600130S, CWS600139S, CWS600113S, CWS600118S, CWS600167S, CWS600707S, CWS600762S, CWS600120S, CWS600121S, CWS600127S, CWS600272S, CWS600371S, CWS600444S, CWS601441S, CWS600166S, CWS601500S, CWS601574S, CWS601991S, CWS600240S, CWS601298S, CWS600128S, CWS600235S, CWS600429S, CWS600455S, CWS601068S, CWS600316S, CWS600473S, CWS600517S, CWS601069S, CWS601238S, CWS600553S, CWS600959S, CWS600973S, CWS601096S, CWS601200S, CWS601226S, CWS602030S, CWS602095S, CWS602097S, CWS602123S, CWS602484S, CWS602605S, CWS600703S, CWS600956S, CWS602838S, CWS602832S, CWS600861S, CWS601353S, CWS602020S, CWS602507S, CWS602564S, CWS601126S, CWS602021S, CWS600137S, CWS600321S, CWS600529S, CWS600814S, CWS602523S, CWS602634S, CWS600152S, CWS601282S, CWS601565S, CWS600154S, CWS600173S, CWS600243S, CWS600320S, CWS600349S, CWS600976S, CWS600998S, CWS601597S, CWS601730S, CWS602496S, CWS601351S, CWS600431S, CWS601528S, CWS602091S, CWS602615S, CWS600252S, CWS600116S, CWS600435S, CWS600507S, CWS600525S, CWS601192S, CWS600265S, CWS600508S, CWS601988S, CWS600144S, CWS600304S, CWS601248S, CWS601990S, CWS601992S, CWS602090S, CWS602606S, CWS600727S, CWS600729S, CWS601092S, CWS601230S, CWS601515S, CWS601538S, CWS601539S, CWS601544S, CWS601631S, CWS600613S, CWS600949S, CWS601221S, CWS601533S, CWS601782S, CWS601559S, CWS602616S, CWS600097S, CWS600249S, CWS600161S, CWS600254S, CWS600257S, CWS601820S, CWS600153S, CWS600441S, CWS600515S, CWS601112S, CWS600417S, CWS601077S, CWS601361S, CWS600162S, CWS600226S, CWS600913S, CWS601805S, CWS601121S, CWS601207S, CWS602444S, CWS601089S, CWS601977S, CWS601315S, CWS601503S, CWS602476S, CWS602477S, CWS600819S, CWS600992S, CWS600350S, CWS600864S, CWS600990S, CWS600995S, CWS601033S, CWS601143S, CWS601190S, CWS601267S, CWS601968S, CWS602204S, CWS600970S, CWS600376S, CWS600481S, CWS600482S, CWS600588S, CWS600823S, CWS600867S, CWS600903S, CWS600664S, CWS600936S, CWS601474S, CWS601575S, CWS602070S, CWS600425S, CWS600811S, CWS602133S, CWS600988S, CWS600424S, CWS600698S, CWS600813S, CWS600881S, CWS600104S, CWS600126S, CWS600135S, CWS600143S, CWS600189S, CWS600224S, CWS600231S, CWS600247S, CWS600340S, CWS600343S, CWS600421S, CWS600427S, CWS600428S, CWS600496S, CWS600683S, CWS600816S, CWS600866S, CWS601480S, CWS600953S, CWS600910S, CWS602388S, CWS602389S, CWS603021S, CWS603022S, CWS600772S, CWS600163S, CWS600356S, CWS601877S, CWS600528S, CWS600323S, CWS600420S, CWS600460S, CWS600469S, CWS600470S, CWS600518S, CWS600519S, CWS600520S, CWS600668S, CWS600697S, CWS600831S, CWS600872S, CWS600878S, CWS600880S, CWS601383S, CWS601426S, CWS601443S, CWS601448S, CWS601572S, CWS601578S, CWS601580S, CWS601808S, CWS602107S, CWS602130S, CWS602159S, CWS602562S, CWS602627S, CWS602751S, CWS602765S, CWS600317S, CWS600442S, CWS600145S, CWS600200S, CWS600221S, CWS600275S, CWS600450S, CWS600835S, CWS600885S, CWS601819S, CWS601261S, CWS601061S, CWS601113S, CWS601320S, CWS601817S, CWS601885S, CWS602010S, CWS602088S, CWS602199S, CWS601339S, CWS601446S, CWS602732S, CWS602737S, CWS601186S, CWS601187S, CWS601331S, CWS601333S, CWS601334S, CWS601459S, CWS601535S, CWS601557S, CWS600722S, CWS601417S, CWS601428S, CWS601547S, CWS602566S, CWS602567S, CWS600319S, CWS600822S, CWS600919S, CWS600954S, CWS601184S, CWS601581S, CWS602506S, CWS602614S, CWS600977S, CWS601545S, CWS601570S, CWS601344S, CWS601345S, CWS601523S, CWS600133S, CWS600134S, CWS601579S, CWS601721S, CWS600146S, CWS601722S, CWS602412S, CWS602841S, CWS602059S, CWS601796S, CWS601464S, CWS601714S, CWS600457S, CWS600874S, CWS600875S, CWS600980S, CWS601078S, CWS601668S, CWS601684S, CWS602004S, CWS602155S, CWS600419S, CWS601472S, CWS602102S, CWS600769S, CWS601513S, CWS600156S, CWS600540S, CWS601610S, CWS600778S, CWS600935S, CWS600957S, CWS601311S, CWS601526S, CWS602057S, CWS602196S, CWS601073S, CWS600493S, CWS600967S, CWS601454S, CWS600578S, CWS601318S, CWS602075S, CWS600706S, CWS601629S, CWS601231S, CWS601242S, CWS601249S, CWS601326S, CWS601561S, CWS601592S, CWS602184S, CWS601781S, CWS601734S, CWS602076S, CWS602617S, CWS602624S, CWS601095S, CWS600559S, CWS601285S, CWS601727S, CWS602434S, CWS600261S, CWS600492S, CWS600780S, CWS601086S, CWS601502S, CWS601621S, CWS601661S, CWS601738S, CWS601787S, CWS602078S, CWS602101S, CWS602887S, CWS602443S, CWS600385S, CWS600416S, CWS600583S, CWS600677S, CWS600711S, CWS600238S, CWS600184S, CWS600227S, CWS600928S, CWS600159S, CWS600160S, CWS600443S, CWS600556S, CWS601093S, CWS600230S, CWS600237S, CWS601250S, CWS601281S, CWS601321S, CWS601468S, CWS600633S, CWS600511S, CWS601878S, CWS600817S, CWS600168S, CWS600229S, CWS600246S, CWS600263S, CWS600264S, CWS600271S, CWS600274S, CWS600378S, CWS600415S, CWS600446S, CWS600527S, CWS600544S, CWS600582S, CWS600587S, CWS600590S, CWS600592S, CWS600593S, CWS600601S, CWS600606S, CWS600680S, CWS600681S, CWS600693S, CWS600694S, CWS600704S, CWS600705S, CWS600708S, CWS600733S, CWS600738S, CWS600763S, CWS600775S, CWS600786S, CWS600833S, CWS600950S, CWS600997S, CWS601029S, CWS601070S, CWS601090S, CWS601097S, CWS601362S, CWS601463S, CWS601606S, CWS601622S, CWS601633S, CWS601663S, CWS601710S, CWS601739S, CWS601742S, CWS601867S, CWS601994S, CWS601998S, CWS602055S, CWS602056S, CWS602072S, CWS602164S, CWS602211S, CWS602431S, CWS602505S, CWS601556S, CWS601530S, CWS601074S, CWS601983S, CWS602929S, CWS600398S, CWS602752S, CWS600433S, CWS601147S, CWS601294S, CWS601297S, CWS601724S, CWS601755S, CWS601873S, CWS602518S, CWS600679S, CWS601082S, CWS600857S, CWS601471S, CWS602031S, CWS600522S, CWS600726S, CWS601197S, CWS601467S, CWS601719S, CWS601821S, CWS602172S, CWS600558S, CWS600923S, CWS600999S, CWS601450S, CWS601537S, CWS602127S, CWS601299S, CWS601600S, CWS601804S, CWS600610S, CWS602094S, CWS600491S, CWS600865S, CWS600870S, CWS601802S, CWS601997S, CWS601347S, CWS600150S, CWS600873S, CWS601103S, CWS600916S, CWS600353S, CWS600410S, CWS600545S, CWS600994S, CWS601726S, CWS602923S, CWS602103S, CWS602622S, CWS600411S, CWS600555S, CWS600871S, CWS601205S, CWS601678S, CWS601687S, CWS601705S, CWS601775S, CWS601872S, CWS601996S, CWS602016S, CWS602026S, CWS602049S, CWS600465S, CWS601040S, CWS601863S, CWS602891S, CWS600611S, CWS601049S, CWS601865S, CWS600754S, CWS600755S, CWS600756S, CWS600757S, CWS600758S, CWS600944S, CWS600946S, CWS600947S, CWS600948S, CWS600958S, CWS600963S, CWS600964S, CWS600966S, CWS601003S, CWS601129S, CWS601130S, CWS601133S, CWS601134S, CWS601135S, CWS601139S, CWS601233S, CWS601234S, CWS601236S, CWS601601S, CWS601603S, CWS601605S, CWS601779S, CWS601786S, CWS601848S, CWS601853S, CWS601857S, CWS601858S, CWS601859S, CWS601860S, CWS601861S, CWS601882S, CWS601893S, CWS601899S, CWS602220S, CWS602221S, CWS602350S, CWS602353S, CWS602354S, CWS602355S, CWS602356S, CWS602357S, CWS602358S, CWS602360S, CWS602361S, CWS602363S, CWS602365S, CWS602366S, CWS602367S, CWS602536S, CWS602537S, CWS602538S, CWS602539S, CWS602540S, CWS602541S, CWS600911S, CWS600914S, CWS600915S, CWS600917S, CWS600918S, CWS600921S, CWS600922S, CWS600925S, CWS600926S, CWS600927S, CWS600929S, CWS600930S, CWS600931S, CWS600932S, CWS600615S, CWS600413S, CWS602533S, CWS601847S, CWS602532S, CWS600552S, CWS601004S, CWS601623S, CWS601191S, CWS600308S, CWS601229S, CWS602435S, CWS602831S, CWS600209S, CWS600358S, CWS600476S, CWS600532S, CWS600564S, CWS600618S, CWS600626S, CWS600627S, CWS600643S, CWS600647S, CWS600750S, CWS600771S, CWS600788S, CWS600825S, CWS600827S, CWS600829S, CWS600837S, CWS600943S, CWS601062S, CWS601107S, CWS601307S, CWS601747S, CWS601758S, CWS600284S, CWS600289S, CWS600311S, CWS600391S, CWS600480S, CWS600487S, CWS600562S, CWS600962S, CWS601626S, CWS602045S, CWS602113S, CWS600199S, CWS600295S, CWS600357S, CWS600644S, CWS600696S, CWS601469S, CWS602313S, CWS602345S, CWS600198S, CWS600203S, CWS600212S, CWS600286S, CWS600402S, CWS600534S, CWS600535S, CWS600561S, CWS600634S, CWS600641S, CWS600645S, CWS600646S, CWS600735S, CWS600779S, CWS600794S, CWS601119S, CWS601170S, CWS601350S, CWS601462S, CWS603015S, CWS600278S, CWS600403S, CWS600404S, CWS600620S, CWS600845S, CWS600938S, CWS601083S, CWS601084S, CWS601278S, CWS601476S, CWS601776S, CWS600380S, CWS600401S, CWS600409S, CWS600489S, CWS600830S, CWS600848S, CWS601306S, CWS602376S, CWS600569S, CWS600621S, CWS600715S, CWS600847S, CWS601110S, CWS602195S, CWS603023S, CWS600218S, CWS600383S, CWS600405S, CWS600448S, CWS600530S, CWS600628S, CWS600642S, CWS600748S, CWS600792S, CWS600826S, CWS601182S, CWS601929S, CWS602170S, CWS600192S, CWS600292S, CWS600467S, CWS600674S, CWS600838S, CWS601108S, CWS601277S, CWS601398S, CWS601569S, CWS601583S, CWS600328S, CWS600330S, CWS600478S, CWS600537S, CWS600538S, CWS600617S, CWS600619S, CWS600790S, CWS600798S, CWS602182S, CWS600195S, CWS600207S, CWS600277S, CWS600749S, CWS601007S, CWS602163S, CWS600208S, CWS600282S, CWS600447S, CWS600622S, CWS600635S, CWS600656S, CWS600730S, CWS600810S, CWS600828S, CWS601171S, CWS602174S, CWS602368S, CWS602379S, CWS602380S, CWS600193S, CWS600623S, CWS600334S, CWS600547S, CWS600625S, CWS600210S, CWS600301S, CWS600313S, CWS600361S, CWS600477S, CWS600563S, CWS600742S, CWS600744S, CWS600869S, CWS601928S, CWS603019S, CWS600211S, CWS600285S, CWS600332S, CWS600393S, CWS600395S, CWS600479S, CWS600486S, CWS600488S, CWS600533S, CWS600536S, CWS600629S, CWS600636S, CWS600673S, CWS600700S, CWS600747S, CWS600791S, CWS600846S, CWS600961S, CWS602378S, CWS600307S, CWS600449S, CWS601473S, CWS602343S, CWS602349S, CWS600194S, CWS600205S, CWS600206S, CWS600217S, CWS600303S, CWS600365S, CWS600406S, CWS600407S, CWS600408S, CWS600438S, CWS600695S, CWS600710S, CWS600713S, CWS600743S, CWS600840S, CWS600900S, CWS600907S, CWS600908S, CWS600939S, CWS601101S, CWS601461S, CWS601608S, CWS601618S, CWS601923S, CWS601924S, CWS602081S, CWS600196S, CWS600359S, CWS600367S, CWS600369S, CWS600484S, CWS600616S, CWS600649S, CWS600701S, CWS600746S, CWS600751S, CWS600795S, CWS600940S, CWS601044S, CWS601177S, CWS601470S, CWS601831S, CWS601841S, CWS602087S, CWS602179S, CWS602209S, CWS602289S, CWS600201S, CWS600202S, CWS600280S, CWS600290S, CWS600337S, CWS600338S, CWS600360S, CWS600531S, CWS600548S, CWS600638S, CWS600709S, CWS600714S, CWS600716S, CWS600745S, CWS600752S, CWS600796S, CWS600797S, CWS600821S, CWS600839S, CWS600941S, CWS600942S, CWS601060S, CWS601764S, CWS602116S, CWS602347S, CWS602186S, CWS600191S, CWS600197S, CWS600213S, CWS600214S, CWS600215S, CWS600216S, CWS600293S, CWS600294S, CWS600296S, CWS600297S, CWS600298S, CWS600382S, CWS600386S, CWS600387S, CWS600389S, CWS600392S, CWS600394S, CWS600396S, CWS600397S, CWS600842S, CWS600843S, CWS601491S, CWS600863S, CWS600504S, CWS600599S, CWS601332S, CWS601367S, CWS601518S, CWS601551S, CWS601567S, CWS601688S, CWS601906S, CWS601907S, CWS601942S, CWS602205S, CWS602216S, CWS602437S, CWS602637S, CWS602833S, CWS602834S, CWS602981S, CWS602984S, CWS602989S, CWS602990S, CWS600157S, CWS600690S, CWS601381S, CWS602052S, CWS602112S, CWS602115S, CWS602306S, CWS602329S, CWS602339S, CWS602390S, CWS602397S, CWS602398S, CWS602441S, CWS602524S, CWS602577S, CWS602581S, CWS602599S, CWS602640S, CWS602645S, CWS602646S, CWS602649S, CWS602652S, CWS602667S, CWS602679S, CWS602703S, CWS602709S, CWS602778S, CWS602786S, CWS602790S, CWS602948S, CWS602949S, CWS602950S, CWS602953S, CWS603092S, CWS603103S, CWS603118S, CWS603130S, CWS603154S, CWS603155S, CWS603158S, CWS603159S, CWS603173S, CWS603174S, CWS603175S, CWS603182S, CWS603202S, CWS603203S, CWS600347S, CWS600354S, CWS600366S, CWS600368S, CWS601378S, CWS601524S, CWS601632S, CWS600098S, CWS600110S, CWS600101S, CWS602394S, CWS602395S, CWS600346S, CWS600906S, CWS601015S, CWS601246S, CWS601585S, CWS602096S, CWS602232S, CWS602309S, CWS602319S, CWS602391S, CWS602392S, CWS602400S, CWS602413S, CWS602517S, CWS602571S, CWS602573S, CWS602575S, CWS602576S, CWS602600S, CWS602639S, CWS602648S, CWS602660S, CWS602661S, CWS602666S, CWS602680S, CWS602738S, CWS602768S, CWS602771S, CWS602772S, CWS602854S, CWS602855S, CWS602945S, CWS602946S, CWS602947S, CWS603078S, CWS603093S, CWS603095S, CWS603186S, CWS603189S, CWS603193S, CWS603200S, CWS603201S, CWS600509S, CWS600894S, CWS601051S, CWS601165S, CWS601525S, CWS601596S, CWS601602S, CWS601823S, CWS601829S, CWS601836S, CWS602430S, CWS600381S, CWS600905S, CWS601401S, CWS602440S, CWS602570S, CWS602582S, CWS602668S, CWS600327S, CWS600374S, CWS601813S, CWS603117S, CWS603172S, CWS601803S, CWS602770S, CWS602783S, CWS602857S, CWS601595S, CWS602089S, CWS602644S, CWS601376S, CWS602297S, CWS600109S, CWS602684S, CWS602694S, CWS602844S, CWS600114S, CWS601011S, CWS600250S, CWS600985S, CWS600176S, CWS600115S, CWS600258S, CWS600437S, CWS600462S, CWS600468S, CWS602034S, CWS600259S, CWS602048S, CWS602050S, CWS602051S, CWS602530S, CWS602601S, CWS602602S, CWS601402S, CWS602410S, CWS602420S, CWS603163S, CWS603164S, CWS603180S, CWS600112S, CWS600310S, CWS601204S, CWS602311S, CWS601377S, CWS600456S, CWS601846S, CWS602177S, CWS602534S, CWS602554S, CWS602555S, CWS602560S, CWS602842S, CWS601016S, CWS602659S, CWS600105S, CWS601552S, CWS601421S, CWS602002S, CWS600604S, CWS600632S, CWS600685S, CWS600724S, CWS600734S, CWS600979S, CWS601038S, CWS601047S, CWS601079S, CWS601081S, CWS601534S, CWS601729S, CWS602100S, CWS602489S, CWS600723S, CWS600809S, CWS601010S, CWS601159S, CWS602497S, CWS602603S, CWS601430S, CWS601030S, CWS601178S, CWS602514S, CWS602545S, CWS603089S, CWS603199S, CWS601403S, CWS600565S, CWS600566S, CWS600567S, CWS600568S, CWS600570S, CWS600572S, CWS600573S, CWS600574S, CWS600576S, CWS600577S, CWS601396S, CWS601584S, CWS601844S, CWS603087S, CWS601251S, CWS601375S, CWS602508S, CWS602201S, CWS602202S, CWS601209S, CWS600182S, CWS600373S, CWS600379S, CWS600466S, CWS601054S, CWS601158S, CWS601237S, CWS601489S, CWS601598S, CWS602544S, CWS602692S, CWS600887S, CWS602025S, CWS600849S, CWS601057S, CWS600516S, CWS601749S, CWS601750S, CWS600225S, CWS602385S, CWS602387S, CWS603169S, CWS603160S, CWS603161S, CWS600175S, CWS600124S, CWS600131S, CWS600136S, CWS600151S, CWS600170S, CWS600188S, CWS600190S, CWS600904S, CWS601180S, CWS601424S, CWS601587S, CWS601830S, CWS602235S, CWS602303S, CWS602776S, CWS601009S, CWS601427S, CWS601590S, CWS601617S, CWS601619S, CWS601839S, CWS601840S, CWS601843S, CWS601845S, CWS601849S, CWS601850S, CWS601851S, CWS601854S, CWS601855S, CWS602029S, CWS602039S, CWS602040S, CWS602041S, CWS602042S, CWS602054S, CWS602061S, CWS602064S, CWS602065S, CWS602068S, CWS602073S, CWS602080S, CWS602082S, CWS602084S, CWS602085S, CWS602098S, CWS602099S, CWS602111S, CWS602529S, CWS602548S, CWS602574S, CWS602579S, CWS602580S, CWS602597S, CWS602598S, CWS602643S, CWS602655S, CWS602656S, CWS602663S, CWS602664S, CWS602681S, CWS602682S, CWS602683S, CWS602781S, CWS602784S, CWS602785S, CWS602788S, CWS602789S, CWS602791S, CWS603165S, CWS603166S, CWS603168S, CWS602372S, CWS602373S, CWS602406S, CWS602673S, CWS602708S, CWS603151S, CWS602635S, CWS600639S, CWS600640S, CWS601509S, CWS601689S, CWS601507S, CWS602453S, CWS601809S, CWS601908S, CWS602131S, CWS602457S, CWS601517S, CWS601914S, CWS601909S, CWS601943S, CWS601956S, CWS601972S, CWS602458S, CWS601432S, CWS601769S, CWS601973S, CWS601974S, CWS600969S, CWS600975S, CWS601053S, CWS601055S, CWS601131S, CWS601148S, CWS600372S, CWS601149S, CWS601160S, CWS601193S, CWS601322S, CWS601650S, CWS601651S, CWS602348S, CWS602487S, CWS602488S, CWS602688S, CWS602722S, CWS602723S, CWS602898S, CWS602908S, CWS602920S, CWS602922S, CWS602924S, CWS602972S, CWS603000S, CWS603144S, CWS601336S, CWS601340S, CWS601349S, CWS601352S, CWS601407S, CWS601408S, CWS601412S, CWS601414S, CWS601415S, CWS601646S, CWS601788S, CWS602478S, CWS602899S, CWS600824S, CWS600924S, CWS600952S, CWS600981S, CWS601039S, CWS601041S, CWS601244S, CWS601356S, CWS601359S, CWS601444S, CWS601751S, CWS601989S, CWS601400S, CWS601418S, CWS601495S, CWS601497S, CWS601499S, CWS601504S, CWS601512S, CWS601516S, CWS601604S, CWS601812S, CWS601905S, CWS601910S, CWS602124S, CWS602125S, CWS602128S, CWS602448S, CWS602451S, CWS602459S, CWS602460S, CWS602461S, CWS602462S, CWS602463S, CWS602464S, CWS602465S, CWS602466S, CWS602467S, CWS602468S, CWS602469S, CWS602470S, CWS602471S, CWS602472S, CWS602473S, CWS602501S, CWS602502S, CWS601532S, CWS600148S, CWS600436S, CWS600440S, CWS600459S, CWS600500S, CWS600554S, CWS601364S, CWS601387S, CWS601800S, CWS602066S, CWS602207S, CWS602227S, CWS602415S, CWS602419S, CWS602596S, CWS602982S, CWS602986S, CWS603005S, CWS603006S, CWS603007S, CWS603008S, CWS603009S, CWS603010S, CWS601577S, CWS601105S, CWS601106S, CWS600329S, CWS600384S, CWS600390S, CWS600688S, CWS602295S, CWS602498S, CWS602658S, CWS602777S, CWS603101S, CWS600740S, CWS600768S, CWS601091S, CWS600879S, CWS601006S, CWS601008S, CWS601031S, CWS601032S, CWS601036S, CWS601042S, CWS602122S, CWS602416S, CWS602417S, CWS602418S, CWS602862S, CWS602863S, CWS602869S, CWS603003S, CWS603004S, CWS601912S, CWS602086S, CWS601188S, CWS601372S, CWS602335S, CWS602954S, CWS603102S, CWS603112S, CWS603115S, CWS603121S, CWS603122S, CWS603123S, CWS603124S, CWS603125S, CWS600339S, CWS600375S, CWS600505S, CWS601005S, CWS601023S, CWS601588S, CWS602071S, CWS602285S, CWS600362S, CWS600691S, CWS600893S, CWS601025S, CWS602092S, CWS602696S, CWS602699S, CWS601834S, CWS602386S, CWS602853S, CWS600637S, CWS602399S, CWS601256S, CWS601257S, CWS601258S, CWS601260S, CWS601262S, CWS601263S, CWS601264S, CWS601265S, CWS601266S, CWS601268S, CWS601269S, CWS601270S, CWS601271S, CWS601272S, CWS601274S, CWS601275S, CWS601276S, CWS601284S, CWS601291S, CWS601293S, CWS600648S, CWS600672S, CWS600675S, CWS600676S, CWS600678S, CWS600650S, CWS603108S, CWS603111S, CWS601327S, CWS600589S, CWS600651S, CWS600653S, CWS600662S, CWS600663S, CWS600665S, CWS600654S, CWS600655S, CWS602129S, CWS602454S, CWS600324S, CWS600512S, CWS600513S, CWS600514S, CWS600579S, CWS600580S, CWS600581S, CWS600584S, CWS600585S, CWS600586S, CWS600789S, CWS600799S, CWS600800S, CWS600801S, CWS600802S, CWS600803S, CWS600836S, CWS600850S, CWS600854S, CWS600972S, CWS601002S, CWS601066S, CWS601067S, CWS601137S, CWS601138S, CWS601335S, CWS601409S, CWS601410S, CWS601576S, CWS602259S, CWS602743S, CWS602876S, CWS602934S, CWS600370S, CWS600388S, CWS601136S, CWS602860S, CWS602044S, CWS601195S, CWS601213S, CWS601235S, CWS601243S, CWS601259S, CWS601273S, CWS601283S, CWS601643S, CWS601647S, CWS601702S, CWS601728S, CWS601746S, CWS601752S, CWS601818S, CWS601832S, CWS601833S, CWS601948S, CWS602137S, CWS602320S, CWS602336S, CWS602481S, CWS602483S, CWS602512S, CWS602513S, CWS602515S, CWS602516S, CWS602519S, CWS602550S, CWS602551S, CWS602552S, CWS602724S, CWS602725S, CWS602735S, CWS602736S, CWS602739S, CWS602939S, CWS602987S, CWS602988S, CWS602993S, CWS602994S, CWS602995S, CWS603044S, CWS603045S, CWS603046S, CWS603047S, CWS603048S, CWS603049S, CWS603052S, CWS603053S, CWS603054S, CWS600107S, CWS602633S, CWS602187S, CWS601357S, CWS601360S, CWS601013S, CWS601406S, CWS601798S, CWS600841S, CWS601012S, CWS601220S, CWS601405S, CWS600851S, CWS601404S, CWS601416S, CWS602452S, CWS600474S, CWS600499S, CWS601691S, CWS601692S, CWS601694S, CWS600853S, CWS602642S, CWS600341S, CWS600377S, CWS601065S, CWS601511S, CWS602780S, CWS602859S, CWS601208S, CWS602650S, CWS601799S, CWS601505S, CWS603197S, CWS603090S, CWS602856S, CWS602588S, CWS601173S, CWS601624S, CWS602161S, CWS602401S, CWS602402S, CWS602438S, CWS602527S, CWS602549S, CWS602584S, CWS602585S, CWS602587S, CWS602641S, CWS602657S, CWS602665S, CWS602669S, CWS602670S, CWS602698S, CWS603082S, CWS603099S, CWS603119S, CWS603146S, CWS603162S, CWS603183S, CWS603187S, CWS601825S, CWS601826S, CWS602340S, CWS602341S, CWS602369S, CWS602370S, CWS601635S, CWS601652S, CWS601657S, CWS601679S, CWS601681S, CWS601733S, CWS601767S, CWS601938S, CWS602110S, CWS602393S, CWS602479S, CWS602490S, CWS602491S, CWS602522S, CWS602525S, CWS602695S, CWS602705S, CWS602767S, CWS602820S, CWS602822S, CWS602894S, CWS602895S, CWS602902S, CWS602906S, CWS602925S, CWS602927S, CWS603142S, CWS603263S, CWS601117S, CWS601185S, CWS601214S, CWS601218S, CWS601308S, CWS601325S, CWS601615S, CWS601667S, CWS601700S, CWS601735S, CWS601763S, CWS601772S, CWS601806S, CWS602359S, CWS602495S, CWS602511S, CWS602546S, CWS602572S, CWS602586S, CWS602704S, CWS602713S, CWS602727S, CWS602914S, CWS602969S, CWS602977S, CWS603156S, CWS603260S, CWS603265S, CWS601026S, CWS601028S, CWS601116S, CWS601128S, CWS601167S, CWS601168S, CWS601169S, CWS601179S, CWS601206S, CWS601212S, CWS601215S, CWS601217S, CWS601227S, CWS601295S, CWS601616S, CWS601682S, CWS601690S, CWS601693S, CWS601696S, CWS601720S, CWS601725S, CWS601731S, CWS601737S, CWS601740S, CWS601754S, CWS601762S, CWS601766S, CWS601768S, CWS601770S, CWS601774S, CWS601777S, CWS601795S, CWS601816S, CWS601837S, CWS601852S, CWS601856S, CWS602233S, CWS602337S, CWS602362S, CWS602364S, CWS602371S, CWS602374S, CWS602381S, CWS602494S, CWS602503S, CWS602504S, CWS602509S, CWS602510S, CWS602520S, CWS602526S, CWS602547S, CWS602553S, CWS602558S, CWS602565S, CWS602613S, CWS602686S, CWS602687S, CWS602689S, CWS602690S, CWS602691S, CWS602693S, CWS602697S, CWS602712S, CWS602728S, CWS602729S, CWS602730S, CWS602731S, CWS602733S, CWS602734S, CWS602740S, CWS602741S, CWS602769S, CWS602787S, CWS602803S, CWS602819S, CWS602872S, CWS602873S, CWS602878S, CWS602892S, CWS602893S, CWS602900S, CWS602901S, CWS602904S, CWS602905S, CWS602907S, CWS602910S, CWS602911S, CWS602912S, CWS602913S, CWS602915S, CWS602979S, CWS602980S, CWS602983S, CWS602985S, CWS603001S, CWS603039S, CWS603055S, CWS603058S, CWS603063S, CWS603064S, CWS603067S, CWS603083S, CWS603086S, CWS603104S, CWS603141S, CWS603147S, CWS603148S, CWS603149S, CWS603153S, CWS603157S, CWS603206S, CWS600892S, CWS601000S, CWS601392S, CWS601394S, CWS601395S, CWS601529S, CWS602294S, CWS602296S, CWS602583S, CWS602442S, CWS601172S, CWS601589S, CWS602298S, CWS602300S, CWS602647S, CWS602653S, CWS603177S, CWS600335S, CWS601018S, CWS601183S, CWS601399S, CWS602409S, CWS602192S, CWS602275S, CWS601154S, CWS601564S, CWS602408S, CWS603120S, CWS601319S, CWS601801S, CWS602119S, CWS602169S, CWS601358S, CWS601369S, CWS601371S, CWS601380S, CWS601382S, CWS601386S, CWS601390S, CWS601391S, CWS601429S, CWS601435S, CWS601555S, CWS601558S, CWS601560S, CWS601827S, CWS602707S, CWS602779S, CWS603145S, CWS603176S, CWS603184S, CWS603191S, CWS602338S, CWS602672S, CWS602782S, CWS602839S, CWS602861S, CWS601970S, CWS602944S, CWS603114S, CWS600896S, CWS600897S, CWS600898S, CWS600899S, CWS600901S, CWS601052S, CWS601099S, CWS601100S, CWS601141S, CWS601144S, CWS601145S, CWS601280S, CWS601290S, CWS601292S, CWS601300S, CWS601341S, CWS601342S, CWS601343S, CWS601365S, CWS601366S, CWS601368S, CWS601370S, CWS601514S, CWS601634S, CWS601636S, CWS601761S, CWS601765S, CWS601773S, CWS601952S, CWS601953S, CWS601965S, CWS601967S, CWS601969S, CWS601975S, CWS601976S, CWS602178S, CWS602190S, CWS602427S, CWS602428S, CWS602429S, CWS602449S, CWS602450S, CWS602589S, CWS602590S, CWS602591S, CWS602592S, CWS602593S, CWS602594S, CWS602595S, CWS602628S, CWS602629S, CWS602636S, CWS602745S, CWS602746S, CWS602747S, CWS602858S, CWS602896S, CWS602897S, CWS602909S, CWS602916S, CWS602936S, CWS602937S, CWS602938S, CWS602542S, CWS600718S, CWS600784S, CWS600844S, CWS600890S, CWS600891S, CWS602167S, CWS602185S, CWS602304S, CWS601506S, CWS601508S, CWS602206S, CWS602222S, CWS602223S, CWS602224S, CWS602225S, CWS602226S, CWS602228S, CWS602229S, CWS602230S, CWS602231S, CWS602234S, CWS602236S, CWS602248S, CWS602249S, CWS602250S, CWS602251S, CWS602252S, CWS602253S, CWS602254S, CWS602255S, CWS602256S, CWS602257S, CWS602258S, CWS602260S, CWS602261S, CWS602262S, CWS602263S, CWS602264S, CWS602265S, CWS602266S, CWS602267S, CWS602268S, CWS602269S, CWS602270S, CWS602271S, CWS602272S, CWS602273S, CWS602276S, CWS602277S, CWS602280S, CWS602281S, CWS602282S, CWS602283S, CWS602284S, CWS602287S, CWS602290S, CWS602291S, CWS602292S, CWS602293S, CWS602307S, CWS602312S, CWS602315S, CWS602316S, CWS602317S, CWS602318S, CWS602321S, CWS602322S, CWS602323S, CWS602324S, CWS602325S, CWS602326S, CWS602327S, CWS602328S, CWS602330S, CWS602331S, CWS602332S, CWS602333S, CWS602334S, CWS602351S, CWS602352S, CWS602403S, CWS602404S, CWS602405S, CWS602407S, CWS602754S, CWS602755S, CWS602756S, CWS602757S, CWS602760S, CWS602761S, CWS602762S, CWS602763S, CWS602773S, CWS602774S, CWS602775S, CWS602792S, CWS602793S, CWS602794S, CWS602795S, CWS602796S, CWS602797S, CWS602798S, CWS602800S, CWS602801S, CWS602802S, CWS602804S, CWS602805S, CWS602806S, CWS602807S, CWS602808S, CWS602809S, CWS602810S, CWS602811S, CWS602812S, CWS602813S, CWS602814S, CWS602815S, CWS602816S, CWS602817S, CWS602818S, CWS602821S, CWS602823S, CWS602824S, CWS602825S, CWS602826S, CWS602827S, CWS602828S, CWS602829S, CWS602830S, CWS601301S, CWS601440S, CWS601451S, CWS601452S, CWS601453S, CWS601455S, CWS601456S, CWS601457S, CWS601458S, CWS601475S, CWS601477S, CWS601479S, CWS601481S, CWS601482S, CWS601484S, CWS601485S, CWS601486S, CWS601488S, CWS601490S, CWS601492S, CWS601522S, CWS601639S, CWS601641S, CWS601642S, CWS601644S, CWS601645S, CWS601648S, CWS601649S, CWS601653S, CWS601655S, CWS601656S, CWS601658S, CWS601659S, CWS601660S, CWS601664S, CWS601665S, CWS601666S, CWS601669S, CWS601670S, CWS601671S, CWS601672S, CWS601673S, CWS601674S, CWS601675S, CWS601676S, CWS601677S, CWS601680S, CWS601683S, CWS601743S, CWS601771S, CWS601887S, CWS601888S, CWS601889S, CWS601890S, CWS601891S, CWS601892S, CWS601894S, CWS601895S, CWS601896S, CWS601897S, CWS601898S, CWS601900S, CWS601901S, CWS601902S, CWS601913S, CWS601915S, CWS601916S, CWS601917S, CWS601918S, CWS601919S, CWS601920S, CWS601922S, CWS601926S, CWS601927S, CWS601930S, CWS601931S, CWS601933S, CWS601934S, CWS601936S, CWS601937S, CWS601939S, CWS601940S, CWS601941S, CWS601944S, CWS601946S, CWS601947S, CWS601949S, CWS601950S, CWS601954S, CWS601955S, CWS601957S, CWS601958S, CWS601959S, CWS601960S, CWS601961S, CWS601963S, CWS601964S, CWS601978S, CWS601982S, CWS601984S, CWS601986S, CWS601987S, CWS601993S, CWS601995S, CWS602000S, CWS602003S, CWS602007S, CWS602008S, CWS602011S, CWS602017S, CWS602018S, CWS602019S, CWS602022S, CWS602023S, CWS602024S, CWS602032S, CWS602035S, CWS602037S, CWS602043S, CWS602046S, CWS602118S, CWS602132S, CWS602134S, CWS602135S, CWS602138S, CWS602140S, CWS602141S, CWS602142S, CWS602143S, CWS602144S, CWS602145S, CWS602147S, CWS602148S, CWS602149S, CWS602150S, CWS602153S, CWS602154S, CWS602156S, CWS602157S, CWS602158S, CWS602162S, CWS602165S, CWS602168S, CWS602173S, CWS602175S, CWS602176S, CWS602183S, CWS602194S, CWS602237S, CWS602238S, CWS602239S, CWS602240S, CWS602241S, CWS602242S, CWS602243S, CWS602244S, CWS602245S, CWS602246S, CWS602247S, CWS602274S, CWS603002S, CWS603011S, CWS603012S, CWS603013S, CWS603014S, CWS603018S, CWS603024S, CWS603026S, CWS603027S, CWS603028S, CWS603029S, CWS603030S, CWS603032S, CWS603033S, CWS603034S, CWS603036S, CWS603037S, CWS603038S, CWS603040S, CWS603041S, CWS603042S, CWS603043S, CWS603051S, CWS603056S, CWS603060S, CWS603061S, CWS603066S, CWS603068S, CWS603069S, CWS602288S, CWS602578S, CWS602671S, CWS602685S, CWS601142S, CWS601423S, CWS601822S, CWS601835S, CWS602093S, CWS602305S, CWS602396S, CWS602528S, CWS601312S, CWS601419S, CWS601708S, CWS601711S, CWS601638S, CWS602651S, CWS603098S, CWS601760S, CWS602436S, CWS602674S, CWS602499S, CWS602662S, CWS602700S, CWS601211S, CWS601697S, CWS601698S, CWS601699S, CWS601701S, CWS601703S, CWS602036S, CWS602146S, CWS602151S, CWS602191S, CWS602197S, CWS602200S, CWS602203S, CWS602210S, CWS602212S, CWS602278S, CWS602299S, CWS602342S, CWS602421S, CWS602426S, CWS602446S, CWS602492S, CWS602543S, CWS602561S, CWS602611S, CWS602619S, CWS602621S, CWS602632S, CWS602706S, CWS602744S, CWS602748S, CWS602750S, CWS602758S, CWS602759S, CWS602764S, CWS602845S, CWS602867S, CWS602874S, CWS602877S, CWS602882S, CWS602885S, CWS602886S, CWS602890S, CWS602917S, CWS602921S, CWS602926S, CWS602930S, CWS602931S, CWS602932S, CWS602935S, CWS602942S, CWS602943S, CWS602951S, CWS602955S, CWS602956S, CWS602996S, CWS603016S, CWS603017S, CWS603025S, CWS603070S, CWS603071S, CWS603072S, CWS603073S, CWS603079S, CWS603085S, CWS603106S, CWS603192S, CWS603208S, CWS603258S, CWS603259S, CWS603266S, CWS603267S, CWS601707S, CWS602104S, CWS602346S, CWS602850S, CWS602919S, CWS602952S, CWS603100S, CWS603198S; GTIN 00763000001575, Lot Numbers: CWS600082S, CWS600057S, CWS600080S, CWS600029S, CWS600055S, CWS600071S, CWS600091S, CWS600076S, CWS600011S, CWS600007S, CWS600060S, CWS600078S, CWS600094S, CWS600049S, CWS600027S, CWS600074S, CWS600093S, CWS600081S, CWS600092S, CWS600013S, CWS600014S, CWS600046S, CWS600034S, CWS600035S, CWS600006S, CWS600048S, CWS600018S, CWS600015S, CWS600070S, CWS600017S, CWS600068S, CWS600022S, CWS600047S, CWS600053S, CWS600059S, CWS600064S, CWS600088S, CWS600009S, CWS600050S, CWS600056S, CWS600026S, CWS600058S, CWS600069S, CWS600004S, CWS600012S, CWS600031S, CWS600008S, CWS600021S, CWS600065S, CWS600066S, CWS600067S, CWS600083S, CWS600084S, CWS600087S, CWS600003S, CWS600075S, CWS600052S, CWS600005S, CWS600085S, CWS600086S, CWS600044S, CWS600036S, CWS600051S, CWS600033S, CWS600023S, CWS600090S, CWS600072S, CWS600079S, CWS600061S; GTIN 00763000611934, Lot Numbers: CWS603316S, CWS603318S, CWS602721S, CWS603337S, CWS603338S, CWS603306S, CWS603309S, CWS603312S, CWS603313S, CWS603315S, CWS603305S, CWS603324S, CWS603336S, CWS603355S, CWS603356S, CWS603357S, CWS603364S, CWS603322S, CWS603323S, CWS602720S, CWS603221S, CWS603287S, CWS603298S, CWS603299S, CWS603301S, CWS603303S, CWS603307S, CWS603317S, CWS603319S, CWS603320S, CWS603321S, CWS603325S, CWS603326S, CWS603327S, CWS603328S, CWS603358S, CWS603219S, CWS603229S, CWS603243S, CWS603256S, CWS603261S, CWS603300S, CWS602991S, CWS603050S, CWS603057S, CWS603233S, CWS603234S, CWS603235S, CWS603255S
Recalling Firm/
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
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 2
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 2831 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 = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.