—#194832

Product

Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1

FDA product code: NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010031S674
Affected lot / code info: a. Model Numbers: DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600120S, RTW600307S; GTIN 00763000178314, Serial Numbers: RTW600018S, RTW600020S, RTW600022S, RTW600025S, RTW600027S, RTW600028S, RTW600029S, RTW600032S, RTW600033S, RTW600034S, RTW600038S, RTW600040S, RTW600041S, RTW600045S, RTW600232S, RTW600316S, RTW600318S, RTW600321S, RTW600324S, RTW600334S, RTW600335S, RTW600336S, RTW600340S, RTW600341S, RTW600344S, RTW600351S, RTW600356S, RTW600359S, RTW600360S, RTW600361S, RTW600364S, RTW600387S, RTW600388S, RTW600389S, RTW600390S, RTW600391S, RTW600392S, RTW600393S, RTW600394S, RTW600395S, RTW600396S, RTW600397S, RTW600398S, RTW600399S, RTW600400S, RTW600401S, RTW600403S, RTW600404S, RTW600405S, RTW600408S, RTW600410S, RTW600412S, RTW600413S, RTW600415S, RTW600417S, RTW600419S, RTW600420S, RTW600421S, RTW600422S, RTW600425S, RTW600426S, RTW600427S, RTW600428S, RTW600430S, RTW600433S, RTW600436S, RTW600441S, RTW600444S, RTW600445S, RTW600449S, RTW600450S, RTW600452S, RTW600453S, RTW600454S, RTW600456S, RTW600459S, RTW600461S, RTW600463S, RTW600465S, RTW600466S, RTW600467S, RTW600468S, RTW600469S, RTW600470S, RTW600471S, RTW600474S, RTW600476S, RTW600478S, RTW600479S, RTW600481S, RTW600482S, RTW600486S, RTW600487S, RTW600488S, RTW600489S, RTW600490S, RTW600492S, RTW600493S, RTW600494S, RTW600495S, RTW600496S, RTW600497S, RTW600498S, RTW600500S, RTW600501S, RTW600502S, RTW600503S, RTW600505S, RTW600506S, RTW600507S, RTW600508S, RTW600509S, RTW600510S, RTW600511S, RTW600512S, RTW600513S, RTW600514S, RTW600515S, RTW600516S, RTW600517S, RTW600518S, RTW600519S, RTW600520S, RTW600521S, RTW600522S, RTW600523S, RTW600529S, RTW600533S, RTW600534S, RTW600536S, RTW600538S, RTW600541S, RTW600544S, RTW600545S, RTW600546S, RTW600549S, RTW600554S; DTPC2D1: GTIN 00763000178307, Serial Numbers: RTX600387S, RTX600584S, RTX600586S, RTX600587S, RTX600597S; GTIN 00763000178321, Serial Numbers: RTX600014S, RTX600015S, RTX600016S, RTX600018S, RTX600022S, RTX600025S, RTX600027S, RTX600028S, RTX600029S, RTX600030S, RTX600034S, RTX600035S, RTX600088S, RTX600163S, RTX600179S, RTX600202S, RTX600231S, RTX600243S, RTX600247S, RTX600249S, RTX600251S, RTX600252S, RTX600258S, RTX600262S, RTX600268S, RTX600269S, RTX600278S, RTX600286S, RTX600463S, RTX600464S, RTX600466S, RTX600467S, RTX600471S, RTX600472S, RTX600474S, RTX600475S, RTX600476S, RTX600477S, RTX600478S, RTX600482S, RTX600483S, RTX600484S, RTX600485S, RTX600486S, RTX600487S, RTX600490S, RTX600491S, RTX600492S, RTX600493S, RTX600494S, RTX600495S, RTX600500S, RTX600501S, RTX600502S, RTX600503S, RTX600505S, RTX600506S, RTX600507S, RTX600508S, RTX600509S, RTX600510S, RTX600511S, RTX600512S, RTX600513S, RTX600514S, RTX600515S, RTX600516S, RTX600517S, RTX600518S, RTX600521S, RTX600530S, RTX600532S, RTX600533S, RTX600534S, RTX600535S, RTX600536S, RTX600537S, RTX600538S, RTX600539S, RTX600541S, RTX600542S, RTX600543S, RTX600544S, RTX600546S, RTX600547S, RTX600548S, RTX600549S, RTX600550S, RTX600551S, RTX600552S, RTX600554S, RTX600555S, RTX600556S, RTX600557S, RTX600558S, RTX600559S, RTX600560S, RTX600561S, RTX600564S, RTX600566S, RTX600567S, RTX600568S, RTX600569S, RTX600570S, RTX600571S, RTX600572S, RTX600573S, RTX600574S, RTX600575S, RTX600576S, RTX600577S, RTX600578S, RTX600579S, RTX600598S, RTX600600S, RTX600602S, RTX600603S, RTX600604S, RTX600605S, RTX600606S, RTX600607S, RTX600608S, RTX600609S, RTX600610S, RTX600611S, RTX600612S, RTX600613S, RTX600615S, RTX600618S, RTX600619S, RTX600620S, RTX600621S, RTX600622S, RTX600623S, RTX600624S, RTX600625S, RTX600626S, RTX600627S, RTX600628S, RTX600629S, RTX600630S, RTX600631S, RTX600632S; b. Model Numbers: DTPC2QQ: GTIN 00763000178253, Serial Numbers: RTS600220S, RTS600260S, RTS600972S; GTIN 00763000178277, Serial Numbers: RTS600014S, RTS600015S, RTS600016S, RTS600017S, RTS600018S, RTS600020S, RTS600022S, RTS600024S, RTS600026S, RTS600027S, RTS600029S, RTS600030S, RTS600031S, RTS600032S, RTS600034S, RTS600035S, RTS600036S, RTS600037S, RTS600038S, RTS600039S, RTS600041S, RTS600042S, RTS600043S, RTS600044S, RTS600045S, RTS600048S, RTS600050S, RTS600051S, RTS600053S, RTS600055S, RTS600056S, RTS600058S, RTS600060S, RTS600061S, RTS600063S, RTS600064S, RTS600066S, RTS600069S, RTS600228S, RTS600235S, RTS600274S, RTS600275S, RTS600281S, RTS600284S, RTS600286S, RTS600292S, RTS600293S, RTS600295S, RTS600296S, RTS600300S, RTS600301S, RTS600302S, RTS600303S, RTS600304S, RTS600305S, RTS600306S, RTS600308S, RTS600309S, RTS600310S, RTS600311S, RTS600312S, RTS600313S, RTS600315S, RTS600317S, RTS600318S, RTS600319S, RTS600320S, RTS600321S, RTS600323S, RTS600325S, RTS600326S, RTS600327S, RTS600328S, RTS600329S, RTS600330S, RTS600331S, RTS600333S, RTS600335S, RTS600337S, RTS600343S, RTS600344S, RTS600345S, RTS600346S, RTS600348S, RTS600349S, RTS600351S, RTS600352S, RTS600353S, RTS600354S, RTS600355S, RTS600356S, RTS600358S, RTS600359S, RTS600360S, RTS600369S, RTS600373S, RTS600425S, RTS600426S, RTS600441S, RTS600484S, RTS600485S, RTS600486S, RTS600487S, RTS600488S, RTS600489S, RTS600490S, RTS600491S, RTS600492S, RTS600493S, RTS600494S, RTS600495S, RTS600496S, RTS600497S, RTS600498S, RTS600510S, RTS600511S, RTS600512S, RTS600513S, RTS600514S, RTS600515S, RTS600516S, RTS600517S, RTS600518S, RTS600519S, RTS600520S, RTS600521S, RTS600522S, RTS600524S, RTS600525S, RTS600526S, RTS600527S, RTS600528S, RTS600529S, RTS600530S, RTS600531S, RTS600532S, RTS600533S, RTS600534S, RTS600535S, RTS600536S, RTS600538S, RTS600539S, RTS600540S, RTS600541S, RTS600542S, RTS600543S, RTS600554S, RTS600555S, RTS600556S, RTS600557S, RTS600558S, RTS600559S, RTS600560S, RTS600561S, RTS600562S, RTS600563S, RTS600564S, RTS600565S, RTS600566S, RTS600567S, RTS600568S, RTS600569S, RTS600570S, RTS600571S, RTS600572S, RTS600573S, RTS600574S, RTS600575S, RTS600576S, RTS600577S, RTS600578S, RTS600579S, RTS600580S, RTS600581S, RTS600582S, RTS600583S, RTS600584S, RTS600585S, RTS600586S, RTS600587S, RTS600588S, RTS600590S, RTS600592S, RTS600596S, RTS600597S, RTS600600S, RTS600605S, RTS600606S, RTS600607S, RTS600610S, RTS600611S, RTS600616S, RTS600629S, RTS600637S, RTS600638S, RTS600639S, RTS600643S, RTS600648S, RTS600650S, RTS600651S, RTS600656S, RTS600661S, RTS600663S, RTS600665S, RTS600667S, RTS600671S, RTS600673S, RTS600675S, RTS600676S, RTS600677S, RTS600679S, RTS600687S, RTS600693S, RTS600697S, RTS600698S, RTS600700S, RTS600705S, RTS600706S, RTS600719S, RTS600720S, RTS600833S, RTS600842S, RTS600846S, RTS600849S, RTS600852S, RTS600857S, RTS600866S, RTS600874S, RTS600880S, RTS600883S, RTS600884S, RTS600885S, RTS600886S, RTS600888S, RTS600889S, RTS600897S, RTS600900S, RTS600901S, RTS600908S, RTS600910S, RTS600911S, RTS600912S, RTS600913S, RTS600914S, RTS600915S, RTS600916S, RTS600917S, RTS600918S, RTS600919S, RTS600920S, RTS600921S, RTS600922S, RTS600923S, RTS600924S, RTS600925S, RTS600926S, RTS600927S, RTS600928S, RTS600929S, RTS600930S, RTS600931S, RTS600932S, RTS600933S, RTS600934S, RTS600936S, RTS600937S, RTS600938S, RTS600939S, RTS600940S, RTS600941S, RTS600943S, RTS600944S, RTS600945S, RTS600947S, RTS600948S, RTS600949S, RTS600957S, RTS600959S, RTS600967S, RTS600991S, RTS600993S, RTS600995S, RTS600997S, RTS600998S, RTS600999S, RTS601000S, RTS601001S, RTS601002S, RTS601003S, RTS601007S, RTS601008S, RTS601009S, RTS601012S, RTS601017S, RTS601019S, RTS601020S, RTS601021S, RTS601022S, RTS601024S, RTS601029S, RTS601034S, RTS601036S, RTS601038S, RTS601039S, RTS601040S, RTS601041S, RTS601042S, RTS601043S, RTS601044S, RTS601045S, RTS601047S, RTS601048S, RTS601049S, RTS601050S, RTS601051S, RTS601052S, RTS601053S, RTS601054S, RTS601055S, RTS601056S, RTS601057S, RTS601058S, RTS601059S, RTS601060S, RTS601061S, RTS601062S, RTS601063S, RTS601064S, RTS601065S, RTS601066S, RTS601067S, RTS601070S, RTS601071S, RTS601082S, RTS601086S, RTS601087S, RTS601091S, RTS601098S, RTS601100S, RTS601101S, RTS601103S, RTS601105S, RTS601107S, RTS601110S, RTS601111S, RTS601112S, RTS601115S, RTS601116S, RTS601117S, RTS601118S, RTS601119S, RTS601120S, RTS601121S, RTS601122S, RTS601123S, RTS601124S, RTS601125S, RTS601126S, RTS601127S, RTS601128S, RTS601129S, RTS601130S, RTS601131S, RTS601132S, RTS601133S, RTS601134S, RTS601135S, RTS601136S, RTS601137S, RTS601138S, RTS601139S, RTS601140S, RTS601141S, RTS601142S, RTS601143S, RTS601144S, RTS601145S, RTS601146S, RTS601147S, RTS601148S, RTS601149S, RTS601150S, RTS601151S, RTS601152S, RTS601155S, RTS601158S, RTS601159S, RTS601160S, RTS601161S, RTS601163S, RTS601164S, RTS601165S, RTS601166S, RTS601167S, RTS601168S, RTS601169S, RTS601170S, RTS601171S, RTS601172S, RTS601173S, RTS601174S, RTS601175S, RTS601176S, RTS601177S, RTS601178S, RTS601179S, RTS601180S, RTS601181S, RTS601182S, RTS601183S, RTS601184S, RTS601185S, RTS601186S, RTS601187S, RTS601188S, RTS601189S, RTS601190S, RTS601191S, RTS601192S, RTS601193S, RTS601194S, RTS601195S, RTS601198S, RTS601199S, RTS601200S, RTS601201S, RTS601202S, RTS601203S, RTS601204S, RTS601205S, RTS601206S, RTS601207S, RTS601208S, RTS601209S, RTS601210S, RTS601211S, RTS601212S, RTS601215S, RTS601216S, RTS601217S, RTS601218S, RTS601219S, RTS601220S, RTS601221S, RTS601223S, RTS601224S, RTS601225S, RTS601226S, RTS601227S, RTS601228S, RTS601229S, RTS601230S, RTS601231S, RTS601232S, RTS601233S, RTS601234S, RTS601235S, RTS601236S, RTS601237S, RTS601238S, RTS601240S, RTS601242S; DTPC2Q1: GTIN 00763000178260, Serial Numbers: RTT600423S, RTT600424S, RTT600434S; GTIN 00763000178284, Serial Numbers: RTT600010S, RTT600015S, RTT600016S, RTT600017S, RTT600023S, RTT600133S, RTT600135S, RTT600142S, RTT600148S, RTT600196S, RTT600204S, RTT600215S, RTT600304S, RTT600305S, RTT600307S, RTT600308S, RTT600309S, RTT600314S, RTT600315S, RTT600316S, RTT600318S, RTT600319S, RTT600323S, RTT600326S, RTT600327S, RTT600329S, RTT600330S, RTT600331S, RTT600334S, RTT600335S, RTT600337S, RTT600338S, RTT600341S, RTT600342S, RTT600343S, RTT600344S, RTT600345S, RTT600346S, RTT600347S, RTT600348S, RTT600350S, RTT600351S, RTT600353S, RTT600354S, RTT600355S, RTT600357S, RTT600358S, RTT600359S, RTT600360S, RTT600361S, RTT600363S, RTT600365S, RTT600368S, RTT600369S, RTT600370S, RTT600371S, RTT600372S, RTT600373S, RTT600374S, RTT600375S, RTT600376S, RTT600377S, RTT600378S, RTT600380S, RTT600382S, RTT600383S, RTT600386S, RTT600387S, RTT600388S, RTT600389S, RTT600391S, RTT600392S, RTT600393S, RTT600394S, RTT600396S, RTT600397S, RTT600398S, RTT600399S, RTT600400S, RTT600401S, RTT600402S, RTT600403S, RTT600404S, RTT600405S, RTT600406S, RTT600407S, RTT600408S, RTT600409S, RTT600410S, RTT600411S, RTT600412S, RTT600413S, RTT600414S, RTT600415S, RTT600416S, RTT600417S, RTT600418S, RTT600419S, RTT600428S, RTT600442S, RTT600443S, RTT600444S, RTT600445S, RTT600446S, RTT600447S, RTT600448S, RTT600449S, RTT600451S, RTT600452S, RTT600454S, RTT600455S.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2022-06-22
Posted by FDA: 2022-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.