Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1770-2023
• Recall Event ID: 92328
• PMA Number: P010031S550
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00643169720749, Lot Serial Numbers: RPL202320H, RPL202797H, RPL202825H, RPL203304H, RPL203279H, RPL203319H, RPL203730H, RPL203754H, RPL204075H, RPL202479H, RPL202565H, RPL202842H, RPL203342H, RPL203518H, RPL203521H, RPL203522H, RPL203534H, RPL203543H, RPL203556H, RPL203602H, RPL203718H, RPL203723H, RPL203785H, RPL203210H, RPL202222H, RPL202318H, RPL202555H, RPL202697H, RPL202831H, RPL203172H, RPL202156H, RPL202223H, RPL202514H, RPL203290H, RPL203308H, RPL203446H, RPL202803H, RPL202347H, RPL202465H, RPL202684H, RPL202688H, RPL202707H, RPL202934H, RPL202972H, RPL203031H, RPL203078H, RPL203345H, RPL203399H, RPL203581H, RPL203623H, RPL203688H, RPL202382H, RPL202497H, RPL202590H, RPL203217H, RPL203225H, RPL203363H, RPL203369H, RPL203428H, RPL203479H, RPL203480H, RPL203484H, RPL203487H, RPL203488H, RPL203500H, RPL203513H, RPL203569H, RPL203794H, RPL202376H, RPL202499H, RPL202905H, RPL202940H, RPL203030H, RPL203784H, RPL203795H, RPL203957H, RPL202146H, RPL202538H, RPL202681H, RPL202892H, RPL202973H, RPL203164H, RPL202397H, RPL203253H, RPL203407H, RPL202200H, RPL202294H, RPL202834H, RPL202859H, RPL203075H, RPL203077H, RPL203104H, RPL203388H, RPL203560H, RPL203567H, RPL203574H, RPL203620H, RPL203670H, RPL202172H, RPL202308H, RPL202322H, RPL202336H, RPL202356H, RPL202440H, RPL202470H, RPL202571H, RPL202608H, RPL202765H, RPL202922H, RPL203011H, RPL203067H, RPL203227H, RPL203263H, RPL203265H, RPL203288H, RPL203376H, RPL203631H, RPL203635H, RPL203641H, RPL203642H, RPL203741H, RPL202613H, RPL202615H, RPL202713H, RPL202781H, RPL202978H, RPL203392H, RPL203503H, RPL203606H, RPL203661H, RPL203664H, RPL203748H, RPL203830H, RPL203930H, RPL203935H, RPL203978H, RPL204015H, RPL204048H, RPL204054H, RPL202464H, RPL202574H, RPL202140H, RPL202191H, RPL202689H, RPL202783H, RPL202853H, RPL202902H, RPL202942H, RPL202993H, RPL203070H, RPL203107H, RPL203127H, RPL203251H, RPL203586H, RPL203662H, RPL203885H, RPL202137H, RPL202196H, RPL202208H, RPL202209H, RPL202218H, RPL202220H, RPL202221H, RPL202269H, RPL202286H, RPL202289H, RPL202310H, RPL202321H, RPL202337H, RPL202353H, RPL202378H, RPL202420H, RPL202445H, RPL202511H, RPL202523H, RPL202566H, RPL202586H, RPL202629H, RPL202640H, RPL202698H, RPL202808H, RPL202816H, RPL202818H, RPL202819H, RPL202823H, RPL202854H, RPL202906H, RPL202924H, RPL202983H, RPL202992H, RPL202999H, RPL203023H, RPL203032H, RPL203043H, RPL203055H, RPL203073H, RPL203102H, RPL203129H, RPL203206H, RPL202147H, RPL202742H, RPL203680H, RPL203746H, RPL203995H, RPL204055H, RPL204078H, RPL203686H, RPL202179H, RPL202245H, RPL202350H, RPL202357H, RPL202447H, RPL202553H, RPL202636H, RPL202766H, RPL202787H, RPL202788H, RPL202789H, RPL202821H, RPL202864H, RPL202900H, RPL202920H, RPL202951H, RPL202953H, RPL203109H, RPL203194H, RPL202362H, RPL202363H, RPL202577H, RPL202578H, RPL202599H, RPL202647H, RPL202776H, RPL202785H, RPL203047H, RPL202802H, RPL202871H, RPL202911H, RPL202979H, RPL203237H, RPL202316H, RPL202518H, RPL202671H, RPL202805H, RPL202811H, RPL202988H, RPL203079H, RPL203182H, RPL203236H, RPL203274H, RPL203410H, RPL203412H, RPL203426H, RPL203473H, RPL203563H, RPL203619H, RPL203656H, RPL203753H, RPL203786H, RPL203907H, RPL203922H, RPL203938H, RPL203956H, RPL203963H, RPL204066H, RPL203038H, RPL203650H, RPL203694H, RPL203993H, RPL204001H, RPL204018H, RPL204052H, RPL204053H, RPL202557H, RPL202923H, RPL202956H, RPL202960H, RPL202961H, RPL203203H, RPL203403H, RPL203405H, RPL203406H, RPL203435H, RPL203436H, RPL203437H, RPL203438H, RPL203483H, RPL203510H, RPL203559H, RPL203594H, RPL203600H, RPL203609H, RPL203640H, RPL203659H, RPL203744H, RPL203751H, RPL203755H, RPL203840H, RPL203844H, RPL203855H, RPL203952H, RPL203964H, RPL203965H, RPL203979H, RPL204056H, RPL202230H, RPL202242H, RPL202513H, RPL202878H, RPL203112H, RPL203395H, RPL203486H, RPL203599H, RPL203674H, RPL203721H, RPL203801H, RPL202700H, RPL203645H, RPL204011H, RPL204059H, RPL202311H, RPL202355H, RPL202516H, RPL202914H, RPL203044H, RPL202184H, RPL202302H, RPL202390H, RPL202761H, RPL202226H, RPL202437H, RPL202832H, RPL202312H, RPL203608H, RPL202232H, RPL202240H, RPL202241H, RPL202360H, RPL202626H, RPL202706H, RPL202734H, RPL202897H, RPL202967H, RPL203053H, RPL203054H, RPL203069H, RPL203359H, RPL203393H, RPL203442H, RPL203501H, RPL203625H, RPL203726H, RPL202152H, RPL202203H, RPL202319H, RPL202573H, RPL202610H, RPL203649H, RPL203789H, RPL203843H, RPL203845H, RPL203848H, RPL203867H, RPL203875H, RPL203886H, RPL203921H, RPL204065H, RPL202142H, RPL202148H, RPL203179H, RPL203326H, RPL203328H, RPL203330H, RPL203331H, RPL203333H, RPL203335H, RPL203336H, RPL203337H, RPL203339H, RPL203341H, RPL203506H, RPL203514H, RPL203535H, RPL203546H, RPL203552H, RPL202275H, RPL202664H, RPL202724H, RPL203060H, RPL201768H, RPL202300H, RPL202822H, RPL202891H, RPL203013H, RPL203016H, RPL203189H, RPL203315H, RPL203420H, RPL203458H, RPL203528H, RPL203990H, RPL202395H, RPL202504H, RPL202546H, RPL202167H, RPL202884H, RPL203440H, RPL202474H, RPL202621H, RPL203169H, RPL202253H, RPL202344H, RPL202345H, RPL202913H, RPL203034H, RPL203249H, RPL203799H, RPL202149H, RPL202270H, RPL202282H, RPL202328H, RPL202339H, RPL202436H, RPL202444H, RPL202481H, RPL202485H, RPL202507H, RPL202603H, RPL202666H, RPL202826H, RPL202865H, RPL202954H, RPL202996H, RPL203000H, RPL203020H, RPL203024H, RPL203035H, RPL203117H, RPL202604H, RPL202810H, RPL202938H, RPL202980H, RPL203321H, RPL203324H, RPL203325H, RPL203371H, RPL203373H, RPL203396H, RPL203401H, RPL203422H, RPL203424H, RPL203427H, RPL203571H, RPL203578H, RPL203610H, RPL203638H, RPL203665H, RPL203690H, RPL203696H, RPL203733H, RPL203774H, RPL203806H, RPL203818H, RPL203826H, RPL203827H, RPL203831H, RPL203849H, RPL203862H, RPL203864H, RPL203866H, RPL203869H, RPL203870H, RPL203874H, RPL203898H, RPL203910H, RPL203931H, RPL203981H, RPL203983H, RPL203991H, RPL204003H, RPL204040H, RPL202848H, RPL202990H, RPL202165H, RPL202177H, RPL202258H, RPL202529H, RPL202609H, RPL203433H, RPL203683H, RPL203776H, RPL203967H, RPL204020H, RPL203105H, RPL203106H, RPL203122H, RPL202189H, RPL203390H, RPL203425H, RPL202227H, RPL202235H, RPL202247H, RPL202307H, RPL202324H, RPL202402H, RPL202524H, RPL202657H, RPL202690H, RPL202704H, RPL202769H, RPL202851H, RPL202935H, RPL203009H, RPL203121H, RPL202371H, RPL202412H, RPL202645H, RPL202768H, RPL203418H, RPL203700H, RPL203859H, RPL203860H, RPL202118H, RPL202264H, RPL202361H, RPL202478H, RPL202506H, RPL202519H, RPL202548H, RPL202744H, RPL202779H, RPL202780H, RPL202883H, RPL202925H, RPL203041H, RPL203064H, RPL203076H, RPL203195H, RPL203464H, RPL203887H, RPL203962H, RPL202668H, RPL202670H, RPL202676H, RPL202677H, RPL202579H, RPL203982H, RPL202274H, RPL202367H, RPL202532H, RPL202944H, RPL202945H, RPL202947H, RPL203141H, RPL203142H, RPL203146H, RPL203329H, RPL203490H, RPL203491H, RPL203492H, RPL203685H, RPL203689H, RPL203691H, RPL203692H, RPL203906H, RPL203909H, RPL203928H, RPL202276H, RPL202793H, RPL203212H, RPL203029H, RPL203414H, RPL203417H, RPL203419H, RPL202400H, RPL202422H, RPL202512H, RPL202815H, RPL202901H, RPL202957H, RPL202958H, RPL203306H, RPL203313H, RPL203364H, RPL203489H, RPL203551H, RPL203572H, RPL203773H, RPL202124H, RPL202126H, RPL202131H, RPL202132H, RPL202133H, RPL202425H, RPL202426H, RPL202427H, RPL202430H, RPL202736H, RPL202737H, RPL203202H, RPL203366H, RPL202197H, RPL202198H, RPL203443H, RPL204014H, RPL204016H, RPL204017H, RPL202229H, RPL202429H, RPL202451H, RPL202456H, RPL202461H, RPL202667H, RPL203268H, RPL204060H, RPL204071H, RPL202587H, RPL202909H, RPL203287H, RPL202168H, RPL202602H, RPL202931H, RPL202933H, RPL203057H, RPL203221H, RPL203250H, RPL203286H, RPL203852H, RPL203901H, RPL203985H, RPL202254H, RPL202262H, RPL202392H, RPL203139H, RPL203482H, RPL203808H, RPL203999H, RPL203731H, RPL203732H, RPL203735H, RPL203736H, RPL202160H, RPL203536H, RPL203783H, RPL203824H, RPL203949H, RPL203961H, RPL202188H, RPL202560H, RPL202635H, RPL202727H, RPL202928H, RPL202984H, RPL203068H, RPL203241H, RPL203266H, RPL203278H, RPL203305H, RPL203457H, RPL203542H, RPL203724H, RPL203758H, RPL203759H, RPL203890H, RPL203897H, RPL203905H, RPL203918H, RPL203919H, RPL203973H, RPL204045H, RPL202305H, RPL202648H, RPL202804H, RPL202812H, RPL203607H, RPL202138H, RPL202492H, RPL203095H, RPL203358H, RPL203360H, RPL203192H, RPL203615H, RPL203778H, RPL203917H, RPL203920H, RPL203933H, RPL203971H, RPL203992H, RPL204067H, RPL201767H, RPL202843H, RPL202889H, RPL203087H, RPL203028H, RPL203191H, RPL203234H, RPL203612H, RPL203624H, RPL203711H, RPL203725H, RPL203737H, RPL203811H, RPL203846H, RPL203847H, RPL203894H, RPL203945H, RPL203954H, RPL204008H, RPL203570H, RPL203854H, RPL202932H, RPL203005H, RPL203244H, RPL203273H, RPL203416H, RPL203423H, RPL203461H, RPL203780H, RPL203884H, RPL203940H, RPL202391H, RPL202655H, RPL202896H, RPL203118H, RPL202297H, RPL202359H, RPL202628H, RPL203074H, RPL203459H, RPL203476H, RPL203558H, RPL203593H, RPL202403H, RPL202632H, RPL203695H, RPL202252H, RPL203566H, RPL202708H, RPL203155H, RPL203083H, RPL203394H, RPL203400H, RPL203515H, RPL203516H, RPL203526H, RPL203527H, RPL203529H, RPL203530H, RPL203531H, RPL203544H, RPL203548H, RPL203554H, RPL203555H, RPL203562H, RPL203564H, RPL203565H, RPL203598H, RPL203613H, RPL203633H, RPL203637H, RPL203654H, RPL203713H, RPL203743H, RPL203762H, RPL203764H, RPL203765H, RPL203787H, RPL203790H, RPL203825H, RPL203833H, RPL203892H, RPL203925H, RPL203944H, RPL203947H, RPL203951H, RPL204007H, RPL202634H, RPL202182H, RPL202943H, RPL203245H, RPL203248H, RPL203573H, RPL203669H, RPL203693H, RPL203842H, RPL204023H, RPL202446H, RPL202575H, RPL202619H, RPL202791H, RPL203019H, RPL203300H, RPL203575H, RPL203972H, RPL203131H, RPL202212H, RPL202620H, RPL203283H, RPL202166H, RPL202554H, RPL203093H, RPL203101H, RPL203431H, RPL204070H, RPL202246H, RPL202463H, RPL202773H, RPL202936H, RPL202949H, RPL203025H, RPL203647H, RPL202115H, RPL202117H, RPL202119H, RPL202121H, RPL202122H, RPL202123H, RPL202569H, RPL202740H, RPL202747H, RPL202748H, RPL202749H, RPL202750H, RPL202751H, RPL202753H, RPL202754H, RPL202755H, RPL202756H, RPL202758H, RPL202762H, RPL203152H, RPL203154H, RPL203156H, RPL203158H, RPL203166H, RPL203167H, RPL203171H, RPL203175H, RPL203176H, RPL203177H, RPL203178H, RPL202669H, RPL202691H, RPL202695H, RPL202772H, RPL202863H, RPL202893H, RPL202894H, RPL202790H, RPL203157H, RPL202977H, RPL203165H, RPL203215H, RPL203255H, RPL203295H, RPL203375H, RPL203614H, RPL202827H, RPL202475H, RPL202701H, RPL202243H, RPL204037H, RPL202238H, RPL202611H, RPL202622H, RPL202643H, RPL202839H, RPL202850H, RPL202867H, RPL202882H, RPL203052H, RPL203065H, RPL203090H, RPL203201H, RPL203211H, RPL203231H, RPL203258H, RPL203289H, RPL203296H, RPL203301H, RPL203309H, RPL203314H, RPL203340H, RPL203343H, RPL203356H, RPL203391H, RPL203411H, RPL203439H, RPL203462H, RPL203533H, RPL203537H, RPL203538H, RPL203539H, RPL203545H, RPL203553H, RPL203577H, RPL203582H, RPL203583H, RPL203584H, RPL203585H, RPL203587H, RPL203588H, RPL203589H, RPL203590H, RPL203719H, RPL203757H, RPL203913H, RPL204019H, RPL204029H, RPL204031H, RPL204032H, RPL204036H, RPL204039H, RPL204058H, RPL202618H, RPL202173H, RPL202186H, RPL202201H, RPL202214H, RPL202334H, RPL202340H, RPL202477H, RPL202482H, RPL202489H, RPL202535H, RPL202654H, RPL202675H, RPL202899H, RPL202624H, RPL202680H, RPL203269H, RPL203684H, RPL203804H, RPL203987H, RPL203881H, RPL203911H, RPL203481H, RPL203857H, RPL203895H, RPL203969H, RPL202415H, RPL202416H, RPL202417H, RPL202674H, RPL202725H, RPL202729H, RPL202730H, RPL202731H, RPL202732H, RPL202946H, RPL203498H, RPL203502H, RPL203727H, RPL203728H, RPL203729H, RPL202163H, RPL202450H, RPL202777H, RPL202881H, RPL203817H, RPL203850H, RPL203856H, RPL202250H, RPL202458H, RPL202521H, RPL202287H, RPL202288H, RPL202291H, RPL202326H, RPL202483H, RPL202694H, RPL202405H, RPL202543H, RPL202589H, RPL202623H, RPL202738H, RPL203027H, RPL203298H, RPL203752H, RPL203756H, RPL203766H, RPL203876H, RPL203959H, RPL203989H, RPL202386H, RPL202627H, RPL202141H, RPL202567H, RPL202588H, RPL202886H, RPL202959H, RPL202963H, RPL203188H, RPL203190H, RPL203270H, RPL203311H, RPL203679H, RPL203747H, RPL202930H, RPL202955H, RPL203136H, RPL203180H, RPL203678H, RPL203663H, RPL202145H, RPL202157H, RPL202180H, RPL202383H, RPL202413H, RPL202526H, RPL202616H, RPL202876H, RPL203408H, RPL202418H, RPL202432H, RPL202434H, RPL202547H, RPL202592H, RPL202678H, RPL202709H, RPL202711H, RPL202712H, RPL202714H, RPL202715H, RPL202717H, RPL202718H, RPL202969H, RPL202970H, RPL202975H, RPL202976H, RPL203186H, RPL203196H, RPL203199H, RPL203322H, RPL203355H, RPL203357H, RPL203468H, RPL203470H, RPL203471H, RPL203475H, RPL203477H, RPL203478H, RPL203493H, RPL203720H, RPL203740H, RPL203745H, RPL204068H, RPL202410H, RPL202539H, RPL202580H, RPL203116H, RPL203148H, RPL203346H, RPL203896H, RPL203916H, RPL204022H, RPL202784H, RPL202248H, RPL202380H, RPL202665H, RPL202847H, RPL202921H, RPL203001H, RPL203108H, RPL203126H, RPL203137H, RPL203218H, RPL203222H, RPL203230H, RPL202151H, RPL202595H, RPL202606H, RPL202760H, RPL202763H, RPL203099H, RPL203782H, RPL203791H, RPL202260H, RPL202685H, RPL202171H, RPL202234H, RPL202299H, RPL202551H, RPL202585H, RPL202641H, RPL202835H, RPL202939H, RPL202962H, RPL202964H, RPL203080H, RPL203242H, RPL203317H, RPL203467H, RPL202190H, RPL202375H, RPL202484H, RPL203264H, RPL203463H, RPL201771H, RPL202161H, RPL202175H, RPL202231H, RPL202292H, RPL202306H, RPL202581H, RPL202771H, RPL202828H, RPL202870H, RPL202890H, RPL202986H, RPL203006H, RPL202301H, RPL202658H, RPL202687H, RPL202806H, RPL203668H, RPL204043H, RPL202600H, RPL203781H, RPL203899H, RPL203900H, RPL203908H, RPL203948H, RPL203953H, RPL204028H, RPL204057H, RPL202199H, RPL202211H, RPL202317H, RPL202368H, RPL202699H, RPL203050H, RPL203072H, RPL203088H, RPL203170H, RPL203254H, RPL203344H, RPL203365H, RPL203413H, RPL203456H, RPL203504H, RPL203520H, RPL203603H, RPL203616H, RPL203622H, RPL203666H, RPL203777H, RPL203805H, RPL203853H, RPL203960H, RPL202194H, RPL202342H, RPL202384H, RPL202419H, RPL202509H, RPL202525H, RPL202257H, RPL202266H, RPL202280H, RPL202379H, RPL202381H, RPL202406H, RPL202205H, RPL202255H, RPL202351H, RPL202396H, RPL202564H, RPL202799H, RPL202824H, RPL203883H, RPL203929H, RPL203932H, RPL203404H, RPL203722H, RPL204050H, RPL204072H, RPL204079H, RPL203327H, RPL202332H, RPL202570H, RPL202576H, RPL204077H, RPL202267H, RPL202527H, RPL202798H, RPL203904H, RPL202174H, RPL202290H, RPL202844H, RPL203071H, RPL202520H, RPL203260H, RPL203882H, RPL204002H, RPL202908H, RPL202950H, RPL202162H, RPL202830H, RPL203988H, RPL202775H, RPL203415H, RPL202874H, RPL203291H, RPL202880H, RPL202904H, RPL203002H, RPL203123H, RPL203485H, RPL203946H, RPL202472H, RPL202679H, RPL203798H, RPL203980H, RPL203984H, RPL202239H, RPL202272H, RPL202331H, RPL202393H, RPL202443H, RPL202501H, RPL202630H, RPL202778H, RPL202792H, RPL202249H, RPL202469H, RPL203285H, RPL203604H, RPL203651H, RPL203977H, RPL204030H, RPL203402H, RPL203568H, RPL203699H, RPL203611H, RPL202134H, RPL202125H, RPL202372H, RPL202530H, RPL202540H, RPL202597H, RPL202836H, RPL202916H, RPL203302H, RPL203703H, RPL203652H, RPL203706H, RPL203714H, RPL203749H, RPL203958H, RPL204000H, RPL203042H, RPL202215H, RPL202861H, RPL202974H, RPL203460H, RPL203466H, RPL203591H, RPL203682H, RPL203934H, RPL204069H, RPL203880H, RPL202952H, RPL203939H, RPL202728H, RPL202741H, RPL203628H, RPL203673H, RPL203697H, RPL203698H, RPL203851H, RPL202143H, RPL202185H, RPL202233H, RPL202438H, RPL202476H, RPL202496H, RPL202703H, RPL202723H, RPL202782H, RPL202997H, RPL203022H, RPL203066H, RPL203281H, RPL203370H, RPL203372H, RPL203381H, RPL203382H, RPL203383H, RPL203386H, RPL203444H, RPL203445H, RPL203872H, RPL203878H, RPL202490H, RPL202915H, RPL203380H, RPL203832H, RPL203997H, RPL204013H, RPL202309H, RPL202424H, RPL202860H, RPL202985H, RPL202994H, RPL203197H, RPL203792H, RPL203800H, RPL203841H, RPL204047H, RPL203775H, RPL202807H, RPL203834H, RPL203835H, RPL203836H, RPL203838H, RPL203893H, RPL203709H, RPL204046H, RPL202873H, RPL203247H, RPL203082H, RPL203183H, RPL203275H, RPL203292H, RPL203323H, RPL203942H, RPL203639H, RPL203653H, RPL203739H, RPL203861H, RPL202409H, RPL202453H, RPL202745H, RPL202746H, RPL202757H, RPL202800H, RPL202968H, RPL203228H, RPL203240H, RPL203280H, RPL203299H, RPL203348H, RPL203349H, RPL203350H, RPL203351H, RPL203353H, RPL203429H, RPL203626H, RPL203676H, RPL203702H, RPL203803H, RPL203821H, RPL203858H, RPL203868H, RPL203888H, RPL203902H, RPL203914H, RPL203994H, RPL203996H, RPL204012H, RPL204021H, RPL204026H, RPL204027H, RPL204049H, RPL204064H, RPL203675H, RPL203716H, RPL203738H, RPL203998H, RPL202817H, RPL203368H, RPL203903H, RPL203968H, RPL202544H, RPL202855H, RPL203597H, RPL203621H, RPL203767H, RPL203768H, RPL203772H, RPL203891H, RPL203561H, RPL203813H, RPL203974H, RPL204062H, RPL203115H, RPL203238H, RPL203432H, RPL203454H, RPL203455H, RPL203465H, RPL203499H, RPL203524H, RPL203605H, RPL203717H, RPL203793H, RPL203926H, RPL204009H, RPL204044H, RPL204073H, RPL204074H, RPL202338H, RPL202277H, RPL202550H, RPL203710H, RPL203816H, RPL203871H, RPL203672H, RPL203865H, RPL203618H, RPL203950H, RPL203256H, RPL203448H, RPL203525H, RPL203595H, RPL203681H, RPL203707H, RPL203708H, RPL203823H, RPL203829H, RPL203915H, RPL203975H, RPL204025H, RPL203579H, RPL204034H; GTIN 00763000059996, Lot Serial Numbers: RPL600197S, RPL600133S, RPL600239S, RPL600048S, RPL600051S, RPL600141S, RPL601305S, RPL600952S, RPL601106S, RPL601107S, RPL601159S, RPL600047S, RPL600050S, RPL600098S, RPL600440S, RPL600512S, RPL600530S, RPL600580S, RPL600585S, RPL600661S, RPL600706S, RPL600709S, RPL601206S, RPL601199S, RPL601204S, RPL600176S, RPL600189S, RPL600426S, RPL600633S, RPL600859S, RPL601339S, RPL601340S, RPL600980S, RPL600631S, RPL601136S, RPL601152S, RPL601153S, RPL601182S, RPL601183S, RPL601178S, RPL601155S, RPL601156S, RPL600726S, RPL601061S, RPL601067S, RPL601077S, RPL601275S, RPL600852S, RPL600854S, RPL600863S, RPL600054S, RPL600079S, RPL600172S, RPL600179S, RPL600181S, RPL600186S, RPL600230S, RPL600232S, RPL600320S, RPL600355S, RPL600381S, RPL600390S, RPL600400S, RPL600430S, RPL600644S, RPL600877S, RPL600959S, RPL600073S, RPL600103S, RPL600123S, RPL600153S, RPL600196S, RPL600207S, RPL600254S, RPL600272S, RPL600333S, RPL600367S, RPL600368S, RPL600452S, RPL600487S, RPL600506S, RPL600068S, RPL600069S, RPL600135S, RPL600136S, RPL600155S, RPL600184S, RPL600185S, RPL600215S, RPL600218S, RPL600222S, RPL600240S, RPL600270S, RPL600274S, RPL600292S, RPL600315S, RPL600323S, RPL600349S, RPL600479S, RPL600582S, RPL600583S, RPL600243S, RPL600319S, RPL600460S, RPL600581S, RPL600584S, RPL600586S, RPL600587S, RPL601010S, RPL601040S, RPL601138S, RPL600386S, RPL600496S, RPL600573S, RPL600777S, RPL601002S, RPL601113S, RPL601115S, RPL601200S, RPL601203S, RPL600283S, RPL600364S, RPL600411S, RPL600458S, RPL600482S, RPL600486S, RPL600494S, RPL600515S, RPL600532S, RPL600543S, RPL600609S, RPL600618S, RPL600620S, RPL600840S, RPL600851S, RPL600870S, RPL600108S, RPL600109S, RPL600126S, RPL600160S, RPL600231S, RPL600351S, RPL600493S, RPL600271S, RPL600564S, RPL600565S, RPL601119S, RPL600483S, RPL600898S, RPL600900S, RPL600128S, RPL600653S, RPL600963S, RPL601000S, RPL601093S, RPL601125S, RPL601137S, RPL601141S, RPL601224S, RPL600042S, RPL600106S, RPL600107S, RPL600119S, RPL600194S, RPL600198S, RPL600199S, RPL600203S, RPL600219S, RPL600225S, RPL600234S, RPL600255S, RPL600266S, RPL600276S, RPL600284S, RPL600290S, RPL600306S, RPL600358S, RPL600365S, RPL600393S, RPL600395S, RPL600401S, RPL600403S, RPL600432S, RPL600454S, RPL600456S, RPL600467S, RPL600664S, RPL600763S, RPL600879S, RPL600339S, RPL601171S, RPL601288S, RPL600089S, RPL601096S, RPL600070S, RPL600162S, RPL600164S, RPL600223S, RPL600250S, RPL600318S, RPL601237S, RPL600953S, RPL601043S, RPL601368S, RPL601036S, RPL601116S, RPL600934S, RPL601034S, RPL600052S, RPL600096S, RPL600183S, RPL600233S, RPL600392S, RPL600422S, RPL600485S, RPL600511S, RPL600556S, RPL600629S, RPL600643S, RPL600749S, RPL600895S, RPL601210S, RPL600989S, RPL601157S, RPL600167S, RPL600340S, RPL600412S, RPL600488S, RPL600658S, RPL601049S, RPL601050S, RPL601083S, RPL601086S, RPL601223S, RPL601253S, RPL600308S, RPL600331S, RPL600332S, RPL600353S, RPL600419S, RPL600472S, RPL600481S, RPL600504S, RPL600555S, RPL600775S, RPL600926S, RPL600991S, RPL600249S, RPL600327S, RPL600673S, RPL601265S, RPL600086S, RPL600118S, RPL600121S, RPL600443S, RPL600147S, RPL600156S, RPL600237S, RPL600744S, RPL600945S, RPL600972S, RPL601005S, RPL601006S, RPL601008S, RPL601018S, RPL601023S, RPL601024S, RPL601082S, RPL601132S, RPL601133S, RPL601165S, RPL601187S, RPL600053S, RPL600143S, RPL600293S, RPL600388S, RPL600427S, RPL600453S, RPL600498S, RPL600520S, RPL600723S, RPL600774S, RPL600910S, RPL601056S, RPL601247S, RPL601337S, RPL601261S, RPL601280S, RPL601279S, RPL600977S, RPL600978S, RPL600468S, RPL600097S, RPL600296S, RPL600727S, RPL601168S, RPL600348S, RPL600656S, RPL600676S, RPL600716S, RPL600717S, RPL600827S, RPL600890S, RPL601089S, RPL601160S, RPL601164S, RPL601216S, RPL601250S, RPL601269S, RPL601312S, RPL600049S, RPL600111S, RPL600204S, RPL600253S, RPL600307S, RPL600328S, RPL600334S, RPL600361S, RPL600424S, RPL600455S, RPL600461S, RPL600684S, RPL600838S, RPL600889S, RPL600901S, RPL600902S, RPL600134S, RPL600150S, RPL600379S, RPL600502S, RPL600529S, RPL600776S, RPL600968S, RPL600363S, RPL600553S, RPL600590S, RPL600061S, RPL600132S, RPL600140S, RPL600113S, RPL600144S, RPL600336S, RPL601129S, RPL601130S, RPL601131S, RPL600935S, RPL600954S, RPL600961S, RPL600962S, RPL600970S, RPL600981S, RPL600986S, RPL601052S, RPL601053S, RPL601064S, RPL601102S, RPL601105S, RPL601120S, RPL601124S, RPL601198S, RPL601214S, RPL600535S, RPL600538S, RPL600540S, RPL600549S, RPL600561S, RPL600589S, RPL600591S, RPL600594S, RPL600599S, RPL600606S, RPL600608S, RPL600615S, RPL600617S, RPL600624S, RPL600640S, RPL600647S, RPL600649S, RPL600665S, RPL600669S, RPL600715S, RPL600729S, RPL600741S, RPL600742S, RPL600752S, RPL600758S, RPL600764S, RPL600768S, RPL600769S, RPL600782S, RPL600814S, RPL600818S, RPL600819S, RPL600862S, RPL600866S, RPL600867S, RPL600868S, RPL600894S, RPL600909S, RPL600920S, RPL600921S, RPL600929S, RPL600642S, RPL601063S, RPL600899S, RPL601068S, RPL601217S, RPL601218S, RPL600216S, RPL600217S, RPL600345S, RPL600420S, RPL600484S, RPL600492S, RPL600524S, RPL600619S, RPL600623S, RPL600740S, RPL601317S, RPL600059S, RPL600062S, RPL600057S, RPL600305S, RPL600341S, RPL600366S, RPL600833S, RPL600864S, RPL600936S, RPL600941S, RPL600947S, RPL600979S, RPL601045S, RPL601047S, RPL601094S, RPL601273S, RPL601323S, RPL600041S, RPL600071S, RPL600072S, RPL600088S, RPL600115S, RPL600116S, RPL600137S, RPL600158S, RPL600163S, RPL600165S, RPL600175S, RPL600187S, RPL600209S, RPL600210S, RPL600211S, RPL600212S, RPL600213S, RPL600235S, RPL600241S, RPL600242S, RPL600256S, RPL600257S, RPL600275S, RPL600282S, RPL600300S, RPL600352S, RPL600370S, RPL600373S, RPL600380S, RPL600410S, RPL600416S, RPL600417S, RPL600438S, RPL600447S, RPL600462S, RPL600463S, RPL600464S, RPL600478S, RPL600517S, RPL600563S, RPL600614S, RPL600708S, RPL600714S, RPL600829S, RPL600843S, RPL600847S, RPL600869S, RPL600908S, RPL600928S, RPL601033S, RPL601331S, RPL601332S, RPL601348S, RPL601179S, RPL601180S, RPL600060S, RPL600632S, RPL600100S, RPL600236S, RPL600303S, RPL600568S, RPL600083S, RPL600151S, RPL600983S, RPL601051S, RPL600076S, RPL600084S, RPL600114S, RPL600117S, RPL600124S, RPL600362S, RPL600446S, RPL600459S, RPL600491S, RPL600405S, RPL600382S, RPL600987S, RPL601062S, RPL601071S, RPL600120S, RPL600387S, RPL600570S, RPL600601S, RPL600602S, RPL600718S, RPL600771S, RPL601365S, RPL601154S, RPL600385S, RPL601238S, RPL600093S, RPL600149S, RPL600220S, RPL600228S, RPL600229S, RPL600285S, RPL600291S, RPL600317S, RPL600346S, RPL600347S, RPL600378S, RPL600394S, RPL600431S, RPL600474S, RPL600531S, RPL601128S, RPL601266S, RPL600092S, RPL600166S, RPL600193S, RPL600224S, RPL600280S, RPL600441S, RPL600621S, RPL600892S, RPL600932S, RPL601211S, RPL600547S, RPL600994S, RPL601021S, RPL601189S, RPL601324S, RPL600304S, RPL600435S, RPL600444S, RPL600592S, RPL600713S, RPL600743S, RPL600756S, RPL600773S, RPL600779S, RPL600897S.RPL600904S, RPL600906S, RPL601274S, RPL600359S, RPL601074S, RPL600139S, RPL600413S, RPL600622S, RPL600943S, RPL600955S, RPL600957S, RPL600958S, RPL600975S, RPL600976S, RPL601011S, RPL601042S, RPL601072S, RPL601081S, RPL601114S, RPL601276S, RPL601342S, RPL601373S, RPL600066S, RPL600081S, RPL600082S, RPL600112S, RPL600161S, RPL600281S, RPL600313S, RPL600343S, RPL600404S, RPL600407S, RPL600421S, RPL600449S, RPL600477S, RPL600505S, RPL600514S, RPL600521S, RPL600522S, RPL600537S, RPL600539S, RPL600550S, RPL600595S, RPL600611S, RPL600636S, RPL600654S, RPL600668S, RPL600672S, RPL600704S, RPL600711S, RPL600747S, RPL600748S, RPL600783S, RPL600820S, RPL600842S, RPL600865S, RPL600896S, RPL600905S, RPL601355S, RPL601205S, RPL600360S, RPL600475S, RPL600760S, RPL600816S, RPL600891S, RPL600903S, RPL600142S, RPL600471S, RPL600476S, RPL600525S, RPL600526S, RPL600043S, RPL600169S, RPL600766S, RPL600956S, RPL600993S, RPL600995S, RPL600996S, RPL600997S, RPL601004S, RPL601009S, RPL601194S, RPL601201S, RPL601272S, RPL600188S, RPL600192S, RPL600195S, RPL600374S, RPL600398S, RPL600439S, RPL600552S, RPL600698S, RPL600823S, RPL600834S, RPL600835S, RPL600848S, RPL600850S, RPL600861S, RPL600878S, RPL600911S, RPL601343S, RPL601282S, RPL601162S, RPL601188S, RPL601221S, RPL601347S, RPL600208S, RPL600357S, RPL600451S, RPL600667S, RPL600724S, RPL600884S, RPL600931S, RPL601103S, RPL600965S, RPL600937S, RPL600948S, RPL601076S, RPL601091S, RPL601122S, RPL601127S, RPL601163S, RPL601192S, RPL601197S, RPL601219S, RPL601242S, RPL601264S, RPL601285S, RPL601293S, RPL601296S, RPL601299S, RPL601300S, RPL600040S, RPL600191S, RPL600221S, RPL600264S, RPL600278S, RPL600286S, RPL600289S, RPL600329S, RPL600384S, RPL600500S, RPL600536S, RPL600579S, RPL600613S, RPL600628S, RPL600634S, RPL600650S, RPL600660S, RPL600712S, RPL600755S, RPL600767S, RPL600839S, RPL600844S, RPL600846S, RPL600872S, RPL600874S, RPL600876S, RPL600912S, RPL601314S, RPL601328S, RPL601123S, RPL601143S, RPL601185S, RPL601239S, RPL601240S, RPL600044S, RPL600168S, RPL600448S, RPL600545S, RPL600567S, RPL600575S, RPL600607S, RPL601174S, RPL600180S, RPL600279S, RPL600145S, RPL600765S, RPL600616S, RPL600657S, RPL600686S, RPL600735S, RPL600751S, RPL600101S, RPL600408S, RPL600527S, RPL600969S, RPL600569S, RPL600990S, RPL601001S, RPL600330S, RPL600598S, RPL601286S, RPL600389S, RPL601058S, RPL600206S, RPL600244S, RPL600719S, RPL600772S, RPL600984S, RPL600999S, RPL601022S, RPL601173S, RPL600338S, RPL600391S, RPL600470S, RPL600480S, RPL600693S, RPL600697S, RPL600738S, RPL600753S, RPL600761S, RPL601309S, RPL601236S, RPL601235S, RPL600065S, RPL600067S, RPL600301S, RPL600402S, RPL600436S, RPL600501S, RPL600571S, RPL600572S, RPL600759S, RPL600780S, RPL600781S, RPL601351S, RPL601278S, RPL600509S, RPL601100S, RPL600080S, RPL600085S, RPL600666S, RPL600858S, RPL600946S, RPL601044S, RPL601087S, RPL601142S, RPL601144S, RPL601145S, RPL601146S, RPL601147S, RPL601148S, RPL601151S, RPL601161S, RPL601177S, RPL601260S, RPL601284S, RPL600138S, RPL600171S, RPL600202S, RPL600247S, RPL600273S, RPL600288S, RPL600298S, RPL600299S, RPL600309S, RPL600310S, RPL600418S, RPL600423S, RPL600425S, RPL600518S, RPL600551S, RPL600558S, RPL600560S, RPL600574S, RPL600600S, RPL600604S, RPL600652S, RPL600655S, RPL600671S, RPL600707S, RPL600725S, RPL600736S, RPL600739S, RPL600815S, RPL600824S, RPL600825S, RPL600826S, RPL600831S, RPL600857S, RPL600880S, RPL600883S, RPL601335S, RPL601367S, RPL601388S, RPL601268S, RPL601345S, RPL600966S, RPL600967S, RPL601241S, RPL601249S, RPL601295S, RPL600045S, RPL600152S, RPL600277S, RPL600534S, RPL600548S, RPL601222S, RPL601327S, RPL600251S, RPL600433S, RPL600495S, RPL600516S, RPL600588S, RPL600597S, RPL600750S, RPL600942S, RPL600974S, RPL601017S, RPL601020S, RPL601035S, RPL601109S, RPL601190S, RPL601213S, RPL601215S, RPL601326S, RPL600056S, RPL600157S, RPL600261S, RPL600262S, RPL600428S, RPL600566S, RPL600648S, RPL600662S, RPL600705S, RPL600728S, RPL600817S, RPL600832S, RPL600836S, RPL600875S, RPL600907S, RPL601330S, RPL601349S, RPL600960S, RPL601097S, RPL601098S, RPL600396S, RPL600399S, RPL600659S, RPL601175S, RPL601176S, RPL601354S, RPL600923S, RPL600949S, RPL600950S, RPL601099S, RPL601110S, RPL601170S, RPL600091S, RPL600104S, RPL600205S, RPL600267S, RPL600376S, RPL600457S, RPL600523S, RPL600544S, RPL600578S, RPL600754S, RPL600885S, RPL600924S, RPL600964S, RPL601212S, RPL600268S, RPL600146S, RPL600429S, RPL600058S, RPL600927S, RPL601252S, RPL601059S, RPL601065S, RPL601172S, RPL601313S, RPL600466S, RPL600473S, RPL600510S, RPL600519S, RPL600542S, RPL600546S, RPL600593S, RPL600626S, RPL600627S, RPL600915S, RPL601374S, RPL600105S, RPL600245S, RPL600246S, RPL600294S, RPL600295S, RPL600302S, RPL600322S, RPL600324S, RPL600325S, RPL600129S, RPL600940S, RPL601013S, RPL601014S, RPL601027S, RPL601066S, RPL601073S, RPL601112S, RPL601196S, RPL601209S, RPL600326S, RPL600637S, RPL600638S, RPL600639S, RPL600663S, RPL600703S, RPL600973S, RPL601092S, RPL600265S, RPL600610S, RPL601025S, RPL601026S, RPL601075S, RPL601090S, RPL601118S, RPL601167S, RPL601169S, RPL601207S, RPL601243S, RPL601244S, RPL601262S, RPL601263S, RPL600039S, RPL600102S, RPL600154S, RPL600252S, RPL600287S, RPL600321S, RPL600356S, RPL600415S, RPL600499S, RPL600503S, RPL600528S, RPL600557S, RPL600576S, RPL600605S, RPL600625S, RPL600670S, RPL600710S, RPL600730S, RPL600737S, RPL600745S, RPL600746S, RPL600821S, RPL600822S, RPL600828S, RPL600914S, RPL600916S, RPL600917S, RPL600918S, RPL600919S, RPL601316S, RPL601290S, RPL601267S, RPL601030S, RPL601193S, RPL601220S, RPL600938S, RPL600603S, RPL601019S, RPL600596S, RPL600507S, RPL601032S, RPL600260S, RPL600350S, RPL600465S, RPL600770S, RPL600849S, RPL600873S, RPL601080S, RPL601310S, RPL600490S, RPL601283S, RPL601346S, RPL600489S, RPL600944S, RPL600971S, RPL600985S, RPL600988S, RPL600992S, RPL600998S, RPL601015S, RPL601016S, RPL601031S, RPL601054S, RPL601078S, RPL601079S, RPL601084S, RPL601150S, RPL601186S, RPL601202S, RPL601208S, RPL601251S, RPL601258S, RPL601259S, RPL601281S, RPL601291S, RPL601303S, RPL601322S, RPL600201S, RPL600248S, RPL600720S, RPL600721S, RPL600722S, RPL600731S, RPL600732S, RPL600733S, RPL600734S, RPL600762S, RPL600837S, RPL600856S, RPL600860S, RPL600886S, RPL600887S, RPL600888S, RPL600893S, RPL600913S, RPL600930S, RPL600830S, RPL601338S, RPL601301S, RPL601039S, RPL601184S
• 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.
• 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