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Crome Implantable Cardioverter Defibrillators with Cardiac… recallZ-1490-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Jun 22, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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).

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1490-2022
Status
Open, Classified
Initiated by the company
Jun 22, 2022
Posted by the FDA
Aug 9, 2022
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
866 units
Product code
NIK
FDA submissions
P010031S674
Distribution
Worldwide Distribution

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (11k characters)

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.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90565).

Sources and updates

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