Reported Jun 22, 2022 · Ongoing
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4;…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Crome Models loaded with CareLink SmartSync Device
- Manager application software D00U005a)
- Crome VR
DVPC3D1DVPC3D4
- b) Crome DR
DDPC3D1DDPC3D4
- c) Crome HF
DTPC2D4DTPC2D1
- d) Crome HF Quad
DTPC2QQDTPC2Q1
- Lot codes and dates
- a) Crome VR
DVPC3D1DVPC3D4
- Model DVPC3D1GTIN 00763000178536
- Serial Numbers
99 of 99 codes
RSG600215SRSG600212SRSG600196SRSG600280SRSG600223SRSG600208SRSG600106SRSG600094SRSG600125SRSG600193SRSG600006SRSG600123SRSG600016SRSG600136SRSG600249SRSG600113SRSG600395SRSG600173SRSG600118SRSG600116SRSG600112SRSG600130SRSG600111SRSG600191SRSG600205SRSG600143SRSG600175SRSG600209SRSG600272SRSG600167SRSG600187SRSG600077SRSG600162SRSG600253SRSG600245SRSG600131SRSG600145SRSG600237SRSG600107SRSG600220SRSG600037SRSG600119SRSG600144SRSG600231SRSG600163SRSG600185SRSG600210SRSG600148SRSG600171SRSG600157SRSG600172SRSG600137SRSG600201SRSG600190SRSG600114SRSG600247SRSG600183SRSG600278SRSG600243SRSG600246S
- Serial Numbers
198 of 198 codes
RSG600313SRSG600079SRSG600306SRSG600105SRSG600103SRSG600317SRSG600379SRSG600330SRSG600063SRSG600315SRSG600316SRSG600335SRSG600334SRSG600333SRSG600332SRSG600311SRSG600444SRSG600050SRSG600070SRSG600320SRSG600052SRSG600327SRSG600371SRSG600319SRSG600089SRSG600041SRSG600039SRSG600057SRSG600054SRSG600053SRSG600072SRSG600383SRSG600324SRSG600445SRSG600325SRSG600314SRSG600087SRSG600322SRSG600073SRSG600382SRSG600363SRSG600337SRSG600025SRSG600368SRSG600084SRSG600013SRSG600008SRSG600009SRSG600029SRSG600014SRSG600007SRSG600012SRSG600042SRSG600023SRSG600026SRSG600024SRSG600404SRSG600377SRSG600458SRSG600366S
- Model DVPC3D4GTIN 00763000178550
- Serial Numbers
209 of 209 codes
RSH600068SRSH600173SRSH600239SRSH600903SRSH600064SRSH600099SRSH601021SRSH600917SRSH600175SRSH600276SRSH600174SRSH600275SRSH600889SRSH600228SRSH601052SRSH601039SRSH600071SRSH600816SRSH600906SRSH601034SRSH600922SRSH601041SRSH600910SRSH600821SRSH600007SRSH600082SRSH600110SRSH600236SRSH600264SRSH600830SRSH600181SRSH600827SRSH600057SRSH601024SRSH600211SRSH601036SRSH600887SRSH600124SRSH600147SRSH600101SRSH600066SRSH600097SRSH600041SRSH600103SRSH600108SRSH600067SRSH600117SRSH600126SRSH600109SRSH600131SRSH600086SRSH600157SRSH600145SRSH600130SRSH600188SRSH600207SRSH600240SRSH600222SRSH600204SRSH600225S
- Serial Numbers
642 of 642 codes
RSH600793SRSH600640SRSH600589SRSH600762SRSH600651SRSH600659SRSH600692SRSH600766SRSH600639SRSH600694SRSH600763SRSH600959SRSH600648SRSH600948SRSH600930SRSH600929SRSH600942SRSH600864SRSH600758SRSH600574SRSH600714SRSH600722SRSH600667SRSH600726SRSH600995SRSH600742SRSH600801SRSH600666SRSH600654SRSH600817SRSH600642SRSH600782SRSH600689SRSH600641SRSH600685SRSH600932SRSH600854SRSH600675SRSH600935SRSH600030SRSH600936SRSH600710SRSH600806SRSH600673SRSH601004SRSH600553SRSH600653SRSH600787SRSH600800SRSH600676SRSH600283SRSH600962SRSH600359SRSH600270SRSH600418SRSH600415SRSH600414SRSH600412SRSH600406SRSH600190S
- b) Crome DR
DDPC3D1DDPC3D4
- Model DDPC3D1GTIN 00763000178413
- Serial Numbers
92 of 92 codes
RSP600249SRSP600057SRSP600253SRSP600085SRSP600386SRSP600014SRSP600075SRSP600150SRSP600148SRSP600089SRSP600091SRSP600114SRSP600189SRSP600210SRSP600394SRSP600273SRSP600130SRSP600216SRSP600256SRSP600245SRSP600149SRSP600068SRSP600069SRSP600066SRSP600083SRSP600112SRSP600132SRSP600404SRSP600136SRSP600076SRSP600096SRSP600224SRSP600211SRSP600209SRSP600154SRSP600392SRSP600267SRSP600060SRSP600104SRSP600163SRSP600152SRSP600276SRSP600250SRSP600187SRSP600203SRSP600221SRSP600217SRSP600230SRSP600398SRSP600190SRSP600079SRSP600219SRSP600059SRSP600372SRSP600346SRSP600065SRSP600095SRSP600049SRSP600145SRSP600070S
- Serial Numbers
153 of 153 codes
RSP600155SRSP600100SRSP600517SRSP600523SRSP600639SRSP600575SRSP600614SRSP600521SRSP600609SRSP600650SRSP600616SRSP600513SRSP600151SRSP600649SRSP600641SRSP600651SRSP600520SRSP600179SRSP600594SRSP600524SRSP600143SRSP600064SRSP600061SRSP600056SRSP600172SRSP600171SRSP600554SRSP600543SRSP600634SRSP600633SRSP600516SRSP600615SRSP600579SRSP600561SRSP600027SRSP600563SRSP600591SRSP600041SRSP600034SRSP600595SRSP600596SRSP600536SRSP600538SRSP600564SRSP600508SRSP600522SRSP600525SRSP600526SRSP600510SRSP600662SRSP600511SRSP600528SRSP600515SRSP600643SRSP600642SRSP600644SRSP600624SRSP600625SRSP600622SRSP600657S
- Model DDPC3D4GTIN 00763000178437
- Serial Numbers
375 of 375 codes
RSQ600736SRSQ600745SRSQ600905SRSQ600975SRSQ600115SRSQ600114SRSQ600113SRSQ600261SRSQ600258SRSQ600257SRSQ600256SRSQ600255SRSQ600740SRSQ601137SRSQ601122SRSQ600996SRSQ601103SRSQ600142SRSQ600055SRSQ600163SRSQ600164SRSQ600936SRSQ600916SRSQ601138SRSQ601108SRSQ600952SRSQ600049SRSQ600051SRSQ600713SRSQ600777SRSQ600991SRSQ600814SRSQ600627SRSQ600831SRSQ600218SRSQ600755SRSQ600783SRSQ600679SRSQ600723SRSQ600772SRSQ600237SRSQ600074SRSQ600913SRSQ600820SRSQ600801SRSQ600685SRSQ600858SRSQ600090SRSQ600712SRSQ600931SRSQ600053SRSQ600012SRSQ600633SRSQ600811SRSQ600843SRSQ600912SRSQ600935SRSQ600894SRSQ600754SRSQ600195S
- Serial Numbers
528 of 528 codes
RSQ600459SRSQ600290SRSQ600435SRSQ601093SRSQ600582SRSQ600593SRSQ600489SRSQ600024SRSQ600494SRSQ601032SRSQ601029SRSQ600554SRSQ600047SRSQ600042SRSQ600027SRSQ600031SRSQ600585SRSQ601042SRSQ601081SRSQ600550SRSQ600926SRSQ601085SRSQ600620SRSQ600655SRSQ600618SRSQ600650SRSQ600643SRSQ600647SRSQ600640SRSQ601009SRSQ601077SRSQ600845SRSQ600832SRSQ600708SRSQ600605SRSQ600530SRSQ600652SRSQ601091SRSQ600046SRSQ600032SRSQ600806SRSQ600727SRSQ600725SRSQ600395SRSQ600635SRSQ600557SRSQ600560SRSQ600847SRSQ600562SRSQ600528SRSQ600190SRSQ601041SRSQ601048SRSQ601046SRSQ601058SRSQ600022SRSQ600851SRSQ600626SRSQ600294SRSQ601011S
- c) Crome HF
DTPC2D4DTPC2D1
- Model DTPC2D4GTIN 00763000178291
- Serial Numbers
267 of 267 codes
RTW600307SRTW600091SRTW600313SRTW600328SRTW600121SRTW600342SRTW600074SRTW600144SRTW600102SRTW600319SRTW600346SRTW600277SRTW600309SRTW600099SRTW600098SRTW600133SRTW600118SRTW600168SRTW600205SRTW600159SRTW600119SRTW600123SRTW600138SRTW600067SRTW600217SRTW600333SRTW600052SRTW600169SRTW600059SRTW600229SRTW600196SRTW600104SRTW600116SRTW600101SRTW600151SRTW600304SRTW600306SRTW600223SRTW600062SRTW600343SRTW600114SRTW600171SRTW600057SRTW600049SRTW600126SRTW600130SRTW600158SRTW600163SRTW600181SRTW600188SRTW600153SRTW600211SRTW600204SRTW600182SRTW600240SRTW600230SRTW600247SRTW600245SRTW600250SRTW600249S
- Model DTPC2D1GTIN 00763000178307
- Serial Numbers
105 of 105 codes
RTX600084SRTX600076SRTX600148SRTX600139SRTX600586SRTX600587SRTX600594SRTX600584SRTX600114SRTX600142SRTX600597SRTX600308SRTX600386SRTX600327SRTX600334SRTX600372SRTX600048SRTX600066SRTX600108SRTX600261SRTX600046SRTX600345SRTX600382SRTX600593SRTX600388SRTX600096SRTX600069SRTX600064SRTX600377SRTX600360SRTX600581SRTX600158SRTX600306SRTX600117SRTX600100SRTX600319SRTX600045SRTX600153SRTX600157SRTX600326SRTX600081SRTX600146SRTX600058SRTX600055SRTX600314SRTX600332SRTX600323SRTX600143SRTX600344SRTX600385SRTX600307SRTX600310SRTX600317SRTX600588SRTX600063SRTX600072SRTX600095SRTX600050SRTX600147SRTX600075S
- a) Crome VR
- Amount recalled
- 3944 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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