Reported Jun 22, 2022 · Ongoing
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005
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?
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Cobalt XT VR: DVPA2D1, DVPA2D4 |
| 2 | Cobalt VR: DVPB3D1, DVPB3D4 |
| 3 | Cobalt XT DR: DDPA2D1, DDPA2D4 |
| 4 | Cobalt DR: DDPB3D1, DDPB3D4 |
| 5 | Cobalt XT HF: DTPA2D4, DTPA2D1 |
| 6 | Cobalt HF: DTPB2D4, DTPB2D1 |
| 7 | Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1 |
| 8 | Cobalt HF Quad: DTPB2QQ, DTPB2Q1 |
- Lot codes and dates
- a) Cobalt XT VRDVPA2D1
- DVPA2D4Model
- DVPA2D1GTIN 00763000178451
- Serial Numbers
670 of 670 codes
RSC600175SRSC600169SRSC600211SRSC600163SRSC600177SRSC600212SRSC600237SRSC600217SRSC601072SRSC601241SRSC601396SRSC600327SRSC600018SRSC600347SRSC600391SRSC600419SRSC601490SRSC600423SRSC600501SRSC600337SRSC600422SRSC600420SRSC600421SRSC601410SRSC601433SRSC600281SRSC600298SRSC600131SRSC601388SRSC600174SRSC600331SRSC600240SRSC600225SRSC600299SRSC600328SRSC600293SRSC601071SRSC601345SRSC601443SRSC601450SRSC601419SRSC600417SRSC600147SRSC600275SRSC601486SRSC601313SRSC601317SRSC601542SRSC601500SRSC601520SRSC600443SRSC601244SRSC601107SRSC601515SRSC601506SRSC601231SRSC601230SRSC601229SRSC601228SRSC601227S
- Serial Numbers
344 of 344 codes
RSC600921SRSC600077SRSC600958SRSC601301SRSC601267SRSC601007SRSC601055SRSC600021SRSC600893SRSC600538SRSC601268SRSC601299SRSC600794SRSC601271SRSC600894SRSC600789SRSC601304SRSC601565SRSC600227SRSC600223SRSC600053SRSC600403SRSC600734SRSC600745SRSC600671SRSC600737SRSC600735SRSC600733SRSC600793SRSC601260SRSC600029SRSC600540SRSC600031SRSC600410SRSC600529SRSC600037SRSC600683SRSC601302SRSC601053SRSC601008SRSC601449SRSC601054SRSC600062SRSC600063SRSC600571SRSC600840SRSC600056SRSC600913SRSC600554SRSC600891SRSC600315SRSC600676SRSC600675SRSC600968SRSC600915SRSC601044SRSC600542SRSC600059SRSC600914SRSC601296S
- Serial Numbers
135 of 135 codes
RSC600906SRSC600576SRSC600531SRSC600955SRSC600108SRSC600873SRSC600117SRSC601013SRSC600973SRSC600068SRSC600591SRSC600557SRSC600901SRSC600875SRSC600556SRSC600561SRSC600934SRSC600942SRSC600528SRSC600859SRSC600102SRSC600104SRSC600600SRSC600558SRSC601562SRSC600853SRSC600614SRSC600979SRSC600105SRSC600871SRSC600083SRSC600868SRSC601279SRSC600602SRSC600097SRSC600566SRSC600537SRSC600119SRSC600854SRSC600584SRSC600985SRSC600954SRSC600070SRSC600957SRSC600587SRSC600109SRSC600608SRSC600095SRSC600458SRSC600563SRSC600594SRSC600977SRSC600943SRSC600522SRSC600974SRSC600937SRSC600998SRSC600266SRSC600067SRSC600944S
- Model DVPA2D4GTIN 00763000178468
- Serial Numbers
257 of 257 codes
RSD601401SRSD603102SRSD603564SRSD603166SRSD603249SRSD602695SRSD600280SRSD600279SRSD601975SRSD601968SRSD601967SRSD601921SRSD601892SRSD602227SRSD602477SRSD601566SRSD602569SRSD601384SRSD601382SRSD601387SRSD601385SRSD600186SRSD602887SRSD600572SRSD600566SRSD602097SRSD602093SRSD602197SRSD602904SRSD602614SRSD603156SRSD602155SRSD602583SRSD602874SRSD601548SRSD600450SRSD603147SRSD602395SRSD602121SRSD602590SRSD602889SRSD603381SRSD603006SRSD603315SRSD603599SRSD602101SRSD601563SRSD600367SRSD602702SRSD603349SRSD602381SRSD602377SRSD601335SRSD603558SRSD602358SRSD600592SRSD602266SRSD600098SRSD601557SRSD602359S
- Serial Numbers
968 of 968 codes
RSD600764SRSD601649SRSD600018SRSD601990SRSD601857SRSD601816SRSD600646SRSD601835SRSD601031SRSD602807SRSD601875SRSD602959SRSD602822SRSD602810SRSD601713SRSD601712SRSD601711SRSD603477SRSD601743SRSD600090SRSD603087SRSD602553SRSD603467SRSD602183SRSD603479SRSD601664SRSD600062SRSD602551SRSD602169SRSD600753SRSD600746SRSD603530SRSD602805SRSD600970SRSD600968SRSD600763SRSD601005SRSD601004SRSD601006SRSD601240SRSD601233SRSD600755SRSD601265SRSD601316SRSD601724SRSD601723SRSD601803SRSD601789SRSD602027SRSD602026SRSD602482SRSD602467SRSD602961SRSD603180SRSD600771SRSD603508SRSD603521SRSD602960SRSD603121SRSD603506S
- Serial Numbers
293 of 293 codes
RSD600738SRSD601503SRSD600649SRSD600735SRSD602436SRSD601221SRSD601636SRSD601474SRSD600675SRSD600804SRSD602148SRSD600068SRSD600066SRSD600757SRSD601027SRSD601275SRSD600085SRSD601515SRSD603275SRSD600670SRSD600079SRSD600070SRSD600698SRSD601194SRSD601710SRSD600637SRSD600152SRSD602964SRSD600119SRSD600073SRSD600102SRSD600131SRSD600631SRSD601702SRSD602125SRSD601707SRSD600706SRSD602449SRSD600657SRSD600673SRSD601699SRSD601768SRSD600642SRSD601540SRSD600662SRSD601755SRSD601195SRSD601703SRSD601267SRSD601343SRSD601393SRSD601048SRSD601781SRSD602126SRSD600648SRSD601656SRSD601113SRSD602508SRSD601090SRSD600643S
- b) Cobalt VRDVPB3D1
- DVPB3D4Model
- DVPB3D1GTIN 00763000178499
- Serial Numbers
RSE600428SRSE600116SRSE600346SRSE600572SRSE600517SRSE600515SRSE600513SRSE600512SRSE600520SRSE600519SRSE600518SRSE600505SRSE601609SRSE601610SRSE601605SRSE601604SRSE601603SRSE601873SRSE601872SRSE601
- Amount recalled
- 51922 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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