Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 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

Recall number

Z-1488-2022

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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

Status

Open, Classified

Initiated

2022-06-22

Posted

2022-08-09

Terminated

not on file

Reason

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).

Root 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

1408 units

Distribution

Worldwide Distribution

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P010031S674"]

Product code

NIK

Firm FEI

2182208

Firm city

Mounds View

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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