Class 1 Device Recall Cobalt

• Date Initiated by Firm: June 22, 2022
• Date Posted: August 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1488-2022
• Recall Event ID: 90565
• PMA Number: P010031S674
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
• Code Information: a. Model Numbers: DTPB2D4: GTIN 00763000178215, Serial Numbers: RTO600239S, RTO600280S, RTO600409S, RTO600468S, RTO600544S, RTO600701S, RTO600712S, RTO601012S, RTO601031S, RTO601113S, RTO601150S, RTO601156S, RTO601205S, RTO601223S, RTO601549S, RTO601612S, RTO601620S, RTO601784S, RTO601793S, RTO601819S, RTO601823S, RTO601830S, RTO601845S, RTO601846S, RTO601858S, RTO601860S, RTO601862S, RTO601891S, RTO601905S, RTO601945S, RTO601960S, RTO601965S, RTO601986S, RTO602000S, RTO602002S, RTO602029S, RTO602031S, RTO602056S, RTO602107S, RTO602110S, RTO602116S, RTO602159S, RTO602164S, RTO602173S, RTO602183S, RTO602224S, RTO602260S, RTO602261S, RTO602266S, RTO602297S, RTO602303S, RTO602308S, RTO602311S, RTO602324S, RTO602326S, RTO602330S, RTO602331S, RTO602333S, RTO602336S, RTO602340S, RTO602354S, RTO602362S, RTO602372S, RTO602375S, RTO602427S, RTO602431S, RTO602435S, RTO602447S, RTO602452S, RTO602468S, RTO602479S, RTO602487S, RTO602493S, RTO602513S, RTO602516S, RTO602520S, RTO602524S, RTO602536S, RTO602544S, RTO602545S, RTO602556S, RTO602562S, RTO602568S, RTO602577S, RTO602578S, RTO602596S, RTO602598S, RTO602600S; GTIN 00763000178239, Serial Numbers: RTO600028S, RTO600029S, RTO600030S, RTO600031S, RTO600033S, RTO600034S, RTO600036S, RTO600037S, RTO600038S, RTO600040S, RTO600041S, RTO600042S, RTO600043S, RTO600045S, RTO600046S, RTO600047S, RTO600048S, RTO600049S, RTO600050S, RTO600051S, RTO600052S, RTO600053S, RTO600054S, RTO600055S, RTO600056S, RTO600057S, RTO600058S, RTO600060S, RTO600061S, RTO600062S, RTO600064S, RTO600067S, RTO600069S, RTO600070S, RTO600136S, RTO600606S, RTO600906S, RTO600960S, RTO600966S, RTO600967S, RTO600970S, RTO600971S, RTO600972S, RTO600973S, RTO600974S, RTO600975S, RTO600977S, RTO600978S, RTO600980S, RTO600983S, RTO600984S, RTO600985S, RTO600986S, RTO600988S, RTO600989S, RTO601010S, RTO601016S, RTO601018S, RTO601022S, RTO601077S, RTO601092S, RTO601099S, RTO601104S, RTO601133S, RTO601162S, RTO601164S, RTO601168S, RTO601172S, RTO601185S, RTO601211S, RTO601217S, RTO601226S, RTO601233S, RTO601241S, RTO601251S, RTO601252S, RTO601253S, RTO601254S, RTO601256S, RTO601257S, RTO601258S, RTO601264S, RTO601265S, RTO601267S, RTO601268S, RTO601269S, RTO601274S, RTO601278S, RTO601280S, RTO601281S, RTO601284S, RTO601290S, RTO601291S, RTO601292S, RTO601298S, RTO601300S, RTO601323S, RTO601333S, RTO601338S, RTO601342S, RTO601344S, RTO601345S, RTO601360S, RTO601364S, RTO601365S, RTO601369S, RTO601370S, RTO601371S, RTO601374S, RTO601379S, RTO601386S, RTO601392S, RTO601393S, RTO601396S, RTO601397S, RTO601398S, RTO601399S, RTO601400S, RTO601402S, RTO601403S, RTO601405S, RTO601411S, RTO601414S, RTO601415S, RTO601440S, RTO601442S, RTO601444S, RTO601462S, RTO601466S, RTO601467S, RTO601957S, RTO601976S, RTO602187S, RTO602216S, RTO602219S, RTO602220S, RTO602222S, RTO602223S, RTO602226S, RTO602228S, RTO602229S, RTO602232S, RTO602233S, RTO602234S, RTO602237S, RTO602238S, RTO602239S, RTO602240S, RTO602241S, RTO602242S, RTO602243S, RTO602245S, RTO602246S, RTO602247S, RTO602248S, RTO602250S, RTO602251S, RTO602253S, RTO602254S, RTO602255S, RTO602272S, RTO602299S, RTO602306S, RTO602313S, RTO602328S, RTO602332S, RTO602349S, RTO602378S, RTO602412S, RTO602414S, RTO602415S, RTO602419S, RTO602420S, RTO602430S, RTO602449S, RTO602450S, RTO602454S, RTO602473S, RTO602481S, RTO602494S, RTO602497S, RTO602500S, RTO602504S, RTO602505S; DTPB2D1: GTIN 00763000178222, Serial Numbers: RTP600231S, RTP600637S, RTP600821S, RTP600936S, RTP600949S, RTP601207S, RTP601642S, RTP601651S, RTP601655S, RTP601658S, RTP601669S, RTP601684S, RTP601772S, RTP601786S, RTP601803S, RTP601838S, RTP601839S, RTP601873S, RTP601908S, RTP601950S, RTP601967S, RTP601975S, RTP601985S, RTP602018S, RTP602050S, RTP602065S, RTP602067S, RTP602101S, RTP602113S, RTP602138S, RTP602141S, RTP602142S, RTP602143S, RTP602144S, RTP602173S, RTP602187S, RTP602188S, RTP602189S, RTP602195S, RTP602203S, RTP602212S, RTP602213S, RTP602221S, RTP602222S, RTP602253S, RTP602255S, RTP602277S, RTP602290S, RTP602291S, RTP602296S, RTP602298S, RTP602301S, RTP602303S, RTP602308S, RTP602313S, RTP602329S, RTP602333S, RTP602372S, RTP602379S, RTP602380S, RTP602381S, RTP602382S, RTP602383S, RTP602384S, RTP602390S, RTP602392S, RTP602408S, RTP602427S, RTP602428S, RTP602429S, RTP602430S, RTP602431S, RTP602433S, RTP602440S, RTP602441S, RTP602445S, RTP602456S, RTP602461S, RTP602471S, RTP602472S, RTP602491S, RTP602492S, RTP602496S, RTP602497S, RTP602500S, RTP602503S, RTP602523S; GTIN 00763000178246, Serial Numbers: RTP600011S, RTP600013S, RTP600014S, RTP600015S, RTP600022S, RTP600023S, RTP600024S, RTP600025S, RTP600026S, RTP600027S, RTP600028S, RTP600029S, RTP600032S, RTP600035S, RTP600037S, RTP600039S, RTP600043S, RTP600044S, RTP600045S, RTP600046S, RTP600047S, RTP600049S, RTP600051S, RTP600055S, RTP600056S, RTP600058S, RTP600061S, RTP600062S, RTP600064S, RTP600265S, RTP600318S, RTP600325S, RTP600337S, RTP600363S, RTP600364S, RTP600365S, RTP600367S, RTP600369S, RTP600370S, RTP600371S, RTP600376S, RTP601365S, RTP601366S, RTP601367S, RTP601368S, RTP601369S, RTP601370S, RTP601371S, RTP601374S, RTP601375S, RTP601376S, RTP601377S, RTP601378S, RTP601379S, RTP601380S, RTP601381S, RTP601382S, RTP601383S, RTP601384S, RTP601385S, RTP601386S, RTP601387S, RTP601388S, RTP601389S, RTP601390S, RTP601391S, RTP601392S, RTP601393S, RTP601394S, RTP601395S, RTP601396S, RTP601398S, RTP601403S, RTP601404S, RTP601405S, RTP601408S, RTP601409S, RTP601410S, RTP601411S, RTP601412S, RTP601414S, RTP601418S, RTP601419S, RTP601423S, RTP601424S, RTP601425S, RTP601426S, RTP601434S, RTP601443S, RTP601444S, RTP601446S, RTP601447S, RTP601449S, RTP601452S, RTP601453S, RTP601454S, RTP601457S, RTP601458S, RTP601459S, RTP601460S, RTP601461S, RTP601462S, RTP601464S, RTP601467S, RTP601470S, RTP601483S, RTP601485S, RTP601489S, RTP601491S, RTP601492S, RTP601496S, RTP601501S, RTP601504S, RTP601505S, RTP601511S, RTP601512S, RTP601513S, RTP601514S, RTP601516S, RTP601518S, RTP601524S, RTP601534S, RTP601539S; b. Model Numbers: DTPB2QQ: GTIN 00763000178178, Serial Numbers: RTK600618S, RTK600835S, RTK601828S, RTK602459S, RTK602776S, RTK602784S, RTK602799S, RTK602818S, RTK602951S, RTK603433S, RTK603475S, RTK603527S, RTK603528S, RTK604363S, RTK604481S, RTK604905S, RTK604930S, RTK604946S, RTK605316S, RTK605413S, RTK605674S, RTK605677S, RTK605685S, RTK605700S, RTK605703S, RTK605708S, RTK605710S, RTK605713S, RTK605714S, RTK605718S, RTK605722S, RTK605794S, RTK605833S, RTK605845S, RTK605848S, RTK605946S, RTK606126S, RTK606418S, RTK606497S, RTK606521S, RTK606803S, RTK606947S, RTK607461S, RTK607582S, RTK607652S, RTK608200S, RTK608230S, RTK608281S, RTK608312S, RTK608428S, RTK608654S, RTK608660S, RTK608677S, RTK608684S, RTK608694S, RTK608698S, RTK608703S, RTK608756S, RTK608774S, RTK608786S, RTK608910S, RTK608911S, RTK608925S, RTK609244S, RTK609484S, RTK609500S, RTK609501S, RTK609502S, RTK609553S, RTK609558S, RTK609561S, RTK609565S, RTK609566S, RTK609567S, RTK609568S, RTK609577S, RTK609589S, RTK609600S, RTK609725S, RTK609774S, RTK609780S, RTK609781S, RTK609782S, RTK609783S, RTK609784S, RTK609785S, RTK609786S, RTK609787S, RTK609791S, RTK609821S, RTK609959S, RTK609972S, RTK609975S, RTK609977S, RTK609978S, RTK610044S, RTK610108S; GTIN 00763000178192, Serial Numbers: RTK600014S, RTK600015S, RTK600023S, RTK600024S, RTK600026S, RTK600027S, RTK600028S, RTK600029S, RTK600030S, RTK600031S, RTK600032S, RTK600033S, RTK600034S, RTK600035S, RTK600037S, RTK600038S, RTK600039S, RTK600041S, RTK600042S, RTK600043S, RTK600044S, RTK600045S, RTK600048S, RTK600050S, RTK600051S, RTK600052S, RTK600053S, RTK600054S, RTK600055S, RTK600056S, RTK600057S, RTK600058S, RTK600059S, RTK600060S, RTK600061S, RTK600062S, RTK600063S, RTK600064S, RTK600065S, RTK600066S, RTK600067S, RTK600068S, RTK600070S, RTK600071S, RTK600072S, RTK600073S, RTK600082S, RTK600083S, RTK600084S, RTK600085S, RTK600086S, RTK600087S, RTK600088S, RTK600089S, RTK600092S, RTK600093S, RTK600094S, RTK600095S, RTK600096S, RTK600097S, RTK600098S, RTK600099S.RTK600100S, RTK600300S, RTK600301S, RTK600303S, RTK600304S, RTK600310S, RTK600311S, RTK600316S, RTK600317S, RTK600318S, RTK600319S, RTK600321S, RTK600322S, RTK600323S, RTK600325S, RTK600327S, RTK600328S, RTK600330S, RTK600331S, RTK600335S, RTK601049S, RTK601341S, RTK601371S, RTK601372S, RTK601379S, RTK601441S, RTK601854S, RTK601858S, RTK601860S, RTK601861S, RTK601862S, RTK601868S, RTK601884S, RTK601885S, RTK601919S, RTK602063S, RTK602064S, RTK602073S, RTK602074S, RTK602075S, RTK602078S, RTK602082S, RTK602084S, RTK602085S, RTK602087S, RTK602091S, RTK602093S, RTK602094S, RTK602098S, RTK602100S, RTK602101S, RTK602102S, RTK602103S, RTK602118S, RTK602123S, RTK602125S, RTK602144S, RTK602145S, RTK602151S, RTK602152S, RTK602154S, RTK602161S, RTK602171S, RTK602181S, RTK602187S, RTK602191S, RTK602194S, RTK602211S, RTK602215S, RTK602216S, RTK602232S, RTK602246S, RTK602363S, RTK602364S, RTK602404S, RTK602542S, RTK602543S, RTK602544S, RTK602545S, RTK602551S, RTK602552S, RTK602554S, RTK602562S, RTK602563S, RTK602571S, RTK602579S, RTK602580S, RTK602587S, RTK602591S, RTK602596S, RTK602602S, RTK602603S, RTK603520S, RTK603536S, RTK603539S, RTK603541S, RTK603547S, RTK603550S, RTK603551S, RTK603557S, RTK603561S, RTK603564S, RTK603565S, RTK603568S, RTK603571S, RTK603574S, RTK603585S, RTK603592S, RTK603594S, RTK603596S, RTK603598S, RTK603606S, RTK603614S, RTK603616S, RTK603617S, RTK603618S, RTK603621S, RTK603622S, RTK603627S, RTK603628S, RTK603629S, RTK603631S, RTK603634S, RTK603636S, RTK603639S, RTK603641S, RTK603653S, RTK603661S, RTK603666S, RTK603673S, RTK603675S, RTK603676S, RTK603677S, RTK603678S, RTK603682S, RTK603684S, RTK603689S, RTK603693S, RTK603699S, RTK603707S, RTK603714S, RTK603724S, RTK603726S, RTK603728S, RTK603730S, RTK603731S, RTK603732S, RTK603733S, RTK603735S, RTK603736S, RTK603737S, RTK603743S, RTK603744S, RTK603745S, RTK603747S, RTK603748S, RTK603750S, RTK603752S, RTK603760S, RTK603766S, RTK603767S, RTK603776S, RTK603807S, RTK603808S, RTK603818S, RTK603835S, RTK603862S, RTK603864S, RTK603876S, RTK604017S, RTK604082S, RTK604146S, RTK604163S, RTK604164S, RTK604169S, RTK604171S, RTK604172S, RTK604177S, RTK604182S, RTK604183S, RTK604185S, RTK604224S, RTK604225S, RTK604228S, RTK604231S, RTK604240S, RTK604241S, RTK604244S, RTK604246S, RTK604254S, RTK604257S, RTK604264S, RTK604266S, RTK604267S, RTK604268S, RTK604269S, RTK604270S, RTK604272S, RTK604273S, RTK604274S, RTK604275S, RTK604283S, RTK604284S, RTK604285S, RTK604286S, RTK604287S, RTK604288S, RTK604289S, RTK604290S, RTK604291S, RTK604292S, RTK604293S, RTK604294S, RTK604295S, RTK604296S, RTK604297S, RTK604299S, RTK604300S, RTK604301S, RTK604302S, RTK604303S, RTK604304S, RTK604305S, RTK604306S, RTK604307S, RTK604308S, RTK604309S, RTK604310S, RTK604311S, RTK604312S, RTK604313S, RTK604314S, RTK604315S, RTK604316S, RTK604317S, RTK604318S, RTK604319S, RTK604320S, RTK604321S, RTK604322S, RTK604323S, RTK604324S, RTK604325S, RTK604326S, RTK604327S, RTK604328S, RTK604329S, RTK604332S, RTK604567S, RTK604620S, RTK604624S, RTK604667S, RTK604714S, RTK604729S, RTK604734S, RTK604746S, RTK604748S, RTK604752S, RTK604754S, RTK604756S, RTK604761S, RTK604763S, RTK604765S, RTK604766S, RTK604771S, RTK604772S, RTK604773S, RTK604774S, RTK604775S, RTK604776S, RTK604778S, RTK604779S, RTK604780S, RTK604782S, RTK604783S, RTK604784S, RTK604785S, RTK604786S, RTK604787S, RTK604788S, RTK604789S, RTK604790S, RTK604791S, RTK604795S, RTK604796S, RTK604797S, RTK604798S, RTK604803S, RTK604806S, RTK604810S, RTK604812S, RTK604815S, RTK604820S, RTK604822S, RTK604823S, RTK604828S, RTK604829S, RTK604844S, RTK604845S, RTK605119S, RTK605120S, RTK605125S, RTK605126S, RTK605127S, RTK605128S, RTK605131S, RTK605132S, RTK605134S, RTK605137S, RTK605138S, RTK605141S, RTK605143S, RTK605145S, RTK605148S, RTK605150S, RTK605151S, RTK605154S, RTK605157S, RTK605158S, RTK605159S, RTK605160S, RTK605161S, RTK605162S, RTK605163S, RTK605165S, RTK605167S, RTK605170S, RTK605172S, RTK605181S, RTK605188S, RTK605192S, RTK605206S, RTK605213S, RTK605256S, RTK605324S, RTK605335S, RTK605338S, RTK605361S, RTK605373S, RTK605381S, RTK605383S, RTK605393S, RTK605417S, RTK605466S, RTK605470S, RTK605485S, RTK605492S, RTK605676S, RTK605951S, RTK606196S, RTK606205S, RTK606256S, RTK606443S, RTK606522S, RTK606526S, RTK606557S, RTK606567S, RTK606572S, RTK606589S, RTK606599S, RTK606613S, RTK606614S, RTK606619S, RTK606620S, RTK606621S, RTK606626S, RTK606627S, RTK606628S, RTK606657S, RTK606662S, RTK606688S, RTK606689S, RTK606693S, RTK606694S, RTK606699S, RTK606712S, RTK606748S, RTK606759S, RTK606784S, RTK606787S, RTK606788S, RTK606814S, RTK606820S, RTK606833S, RTK606837S, RTK606851S, RTK606864S, RTK606996S, RTK607036S, RTK607152S, RTK607154S, RTK607223S, RTK607324S, RTK607554S, RTK607661S, RTK607665S, RTK607675S, RTK607720S, RTK607727S, RTK607731S, RTK607760S, RTK607761S, RTK607764S, RTK607765S, RTK607766S, RTK607772S, RTK607776S, RTK607782S, RTK607787S, RTK607802S, RTK607807S, RTK607811S, RTK607828S, RTK607829S, RTK607830S, RTK607831S, RTK607834S, RTK607835S, RTK607836S, RTK607838S, RTK607840S, RTK607842S, RTK607843S, RTK607844S, RTK607845S, RTK607847S, RTK607852S, RTK607866S, RTK607871S, RTK607874S, RTK607876S, RTK607877S, RTK607881S, RTK607882S, RTK607890S, RTK607892S, RTK607903S, RTK607927S, RTK607928S, RTK607931S, RTK607935S, RTK607943S, RTK607946S, RTK607948S, RTK607950S, RTK607951S, RTK607952S, RTK607964S, RTK607970S, RTK607972S, RTK607973S, RTK607974S, RTK607978S, RTK607980S, RTK607983S, RTK607984S, RTK607988S, RTK607993S, RTK607995S, RTK607997S, RTK607998S, RTK607999S, RTK608971S, RTK609002S, RTK609093S, RTK609487S, RTK609493S, RTK609496S, RTK609499S, RTK609512S, RTK609517S, RTK609527S, RTK609557S, RTK609559S, RTK609560S, RTK609562S, RTK609564S, RTK609570S, RTK609571S, RTK609572S, RTK609574S, RTK609576S, RTK609580S, RTK609581S, RTK609588S, RTK609605S, RTK609606S, RTK609607S, RTK609608S, RTK609611S, RTK609613S, RTK609614S, RTK609615S, RTK609617S, RTK609684S, RTK609687S, RTK609710S, RTK609855S, RTK609888S, RTK609897S, RTK609899S, RTK609921S, RTK609924S, RTK609937S, RTK609947S, RTK609948S, RTK609950S, RTK609951S, RTK609952S, RTK609955S, RTK609960S, RTK609962S, RTK609963S, RTK609964S, RTK609966S, RTK609967S, RTK609968S, RTK609969S, RTK609970S, RTK609973S, RTK609974S, RTK609976S, RTK609979S, RTK609980S, RTK609983S, RTK609984S, RTK609987S, RTK609990S, RTK609995S, RTK609999S, RTK610008S, RTK610011S, RTK610013S, RTK610018S, RTK610019S, RTK610022S, RTK610023S, RTK610027S, RTK610028S, RTK610029S, RTK610031S, RTK612662S, RTK612665S; DTPB2Q1: GTIN 00763000178185, Serial Numbers: RTL600106S, RTL600179S, RTL600278S, RTL600345S, RTL600518S, RTL600524S, RTL600756S, RTL600786S, RTL600788S, RTL600802S, RTL600845S, RTL600979S, RTL601099S, RTL601105S, RTL601116S, RTL601128S, RTL601131S, RTL601166S, RTL601169S, RTL601177S, RTL601196S, RTL601199S, RTL601242S, RTL601250S, RTL601284S, RTL601316S, RTL601322S, RTL601325S, RTL601326S, RTL601339S, RTL601344S, RTL601345S, RTL601364S, RTL601368S, RTL601386S, RTL601391S, RTL601402S, RTL601408S, RTL601410S, RTL601423S, RTL601424S, RTL601427S, RTL601432S, RTL601439S, RTL601440S, RTL601474S, RTL601478S, RTL601480S, RTL601482S, RTL601488S, RTL601490S, RTL601491S, RTL601495S, RTL601507S, RTL601536S, RTL601549S, RTL601554S, RTL601574S, RTL601576S, RTL601585S, RTL601595S, RTL601601S, RTL601609S, RTL601616S, RTL601619S, RTL601621S, RTL601630S, RTL601639S, RTL601641S, RTL601643S, RTL601648S, RTL601660S, RTL601661S, RTL601664S, RTL601676S, RTL601679S, RTL601682S, RTL601687S, RTL601705S, RTL601706S, RTL601707S, RTL601708S, RTL601711S, RTL601715S, RTL601723S, RTL601729S, RTL601731S, RTL601732S, RTL601735S, RTL601736S, RTL601753S, RTL601760S, RTL601762S, RTL601764S, RTL601767S, RTL601772S, RTL601776S, RTL601777S, RTL601778S, RTL601779S, RTL601789S, RTL601801S, RTL601809S, RTL601812S, RTL601815S, RTL601816S, RTL601820S, RTL601821S, RTL601825S, RTL601826S, RTL601829S, RTL601830S, RTL601832S, RTL601850S, RTL601852S, RTL601857S, RTL601859S, RTL601862S, RTL601864S, RTL601873S, RTL601876S, RTL601877S, RTL601878S, RTL601879S, RTL601880S, RTL601881S, RTL601882S, RTL601883S, RTL601884S, RTL601885S, RTL601888S, RTL601890S, RTL601891S, RTL601892S, RTL601893S, RTL601894S, RTL601896S, RTL601912S; GTIN 00763000178208, Serial Numbers: RTL600005S, RTL600007S, RTL600008S, RTL600010S, RTL600014S, RTL600017S, RTL600022S, RTL600023S, RTL600027S, RTL600030S, RTL600032S, RTL600036S, RTL600037S, RTL600038S, RTL600040S, RTL600042S, RTL600043S, RTL600044S, RTL600050S, RTL600069S, RTL600071S, RTL600072S, RTL600074S, RTL600076S, RTL600079S, RTL600086S, RTL600096S, RTL600097S, RTL600098S, RTL600099S, RTL600100S, RTL600102S, RTL600103S, RTL600970S, RTL600973S, RTL600981S, RTL600984S, RTL600993S, RTL601004S, RTL601018S, RTL601028S, RTL601037S, RTL601043S, RTL601047S, RTL601285S, RTL601447S, RTL601448S, RTL601479S, RTL601499S, RTL601503S, RTL601504S, RTL601505S, RTL601509S, RTL601511S, RTL601514S, RTL601515S, RTL601518S, RTL601519S, RTL601521S, RTL601525S, RTL601529S, RTL601539S, RTL601548S, RTL601578S, RTL601580S, RTL601581S, RTL601625S, RTL601626S, RTL601628S, RTL601633S, RTL601635S, RTL601645S, RTL601655S, RTL601657S, RTL601717S, RTL601725S, RTL601742S, RTL601743S, RTL601748S, RTL601749S, RTL601750S, RTL601751S, RTL601752S, RTL601754S, RTL601755S, RTL601759S.
• 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; 763-723-4636
• Manufacturer Reason for Recall: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
• FDA Determined Cause: Device Design
• Action: Beginning 22-JUN-2022 communications to all affected consignees began. In the United States notifications are sent via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. 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. Consignees are asked to quarantine the subset of unused identified Cobalt and Crome devices for retrieval due to potential manufacturing non-conformance and return the inventory to Medtronic. On approximately 08/10/2022, Medtronic notified Risk Managers of the availability of a SW update and actions specific to update the SW on the SmartSync devices, that will in turn update the patient's implanted device during their next clinic visit. In addition, on this same date, a separate communication dated August 2022 is being sent to all affected Implanting Physicians notifying them that a SW update is available and recommended actions to correct this issue with their patient's implanted device. The second notification to physicians did not request returned confirmation.
• Quantity in Commerce: 1408 units
• Distribution: Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

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

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