Reported Aug 17, 2022 · Ongoing
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD,…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.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
- Implantable Cardioverter Defibrillatorsa. Cobalt VR ICD
- Model Numbers
DVPB3D1DVPB3D4b. Cobalt DR ICD
- Model Numbers
DDPB3D1DDPB3D4
- Lot codes and dates
- a
- Model NumbersDVPB3D1: GTIN 00763000178499
- Serial Numbers
147 of 147 codes
RSE600212SRSE600229SRSE600406SRSE600450SRSE600505SRSE600518SRSE600519SRSE600520SRSE600538SRSE600539SRSE600621SRSE600676SRSE600681SRSE600709SRSE600715SRSE600716SRSE600717SRSE600718SRSE600725SRSE600748SRSE600756SRSE600768SRSE601500SRSE601523SRSE601579SRSE601590SRSE601603SRSE601702SRSE601705SRSE601716SRSE601718SRSE601729SRSE601746SRSE601747SRSE601768SRSE601774SRSE601780SRSE601791SRSE601802SRSE601819SRSE601828SRSE601835SRSE601841SRSE601846SRSE601857SRSE601879SRSE601885SRSE601889SRSE601890SRSE601894SRSE601899SRSE601900SRSE601906SRSE601910SRSE601914SRSE601930SRSE601935SRSE601936SRSE601937SRSE601939S
- Serial Numbers
287 of 287 codes
RSE600007SRSE600009SRSE600011SRSE600012SRSE600014SRSE600015SRSE600016SRSE600017SRSE600019SRSE600020SRSE600023SRSE600024SRSE600025SRSE600028SRSE600030SRSE600033SRSE600034SRSE600036SRSE600041SRSE600042SRSE600044SRSE600046SRSE600048SRSE600049SRSE600053SRSE600054SRSE600059SRSE600060SRSE600062SRSE600067SRSE600068SRSE600069SRSE600071SRSE600072SRSE600073SRSE600075SRSE600076SRSE600077SRSE600079SRSE600080SRSE600086SRSE600090SRSE600091SRSE600092SRSE600093SRSE600094SRSE600168SRSE600559SRSE600679SRSE600683SRSE600772SRSE600874SRSE601010SRSE601013SRSE601160SRSE601161SRSE601162SRSE601163SRSE601165SRSE601166S
- DVPB3D4GTIN 00763000178512
- Serial Numbers
89 of 89 codes
RSF600173SRSF601052SRSF601153SRSF601202SRSF601346SRSF601408SRSF601414SRSF601420SRSF601421SRSF601428SRSF601564SRSF601585SRSF602664SRSF602685SRSF602807SRSF602911SRSF602915SRSF602917SRSF602937SRSF602996SRSF603382SRSF603499SRSF603500SRSF603529SRSF603631SRSF604041SRSF604048SRSF604060SRSF604100SRSF604102SRSF604106SRSF604157SRSF604163SRSF604172SRSF604190SRSF604192SRSF604210SRSF604214SRSF604218SRSF604220SRSF604223SRSF604437SRSF604439SRSF604480SRSF604483SRSF604487SRSF604574SRSF604575SRSF604578SRSF604579SRSF604581SRSF604588SRSF604590SRSF604592SRSF604593SRSF604625SRSF604627SRSF604630SRSF604654SRSF604663S
- Serial Numbers
1,047 of 1,047 codes
RSF600008SRSF600009SRSF600011SRSF600013SRSF600014SRSF600016SRSF600017SRSF600018SRSF600019SRSF600020SRSF600021SRSF600022SRSF600023SRSF600024SRSF600025SRSF600026SRSF600027SRSF600028SRSF600029SRSF600030SRSF600031SRSF600032SRSF600033SRSF600034SRSF600035SRSF600036SRSF600037SRSF600038SRSF600039SRSF600041SRSF600042SRSF600043SRSF600044SRSF600045SRSF600048SRSF600050SRSF600051SRSF600052SRSF600055SRSF600057SRSF600058SRSF600059SRSF600060SRSF600061SRSF600062SRSF600064SRSF600065SRSF600066SRSF600067SRSF600068SRSF600069SRSF600070SRSF600071SRSF600072SRSF600073SRSF600074SRSF600076SRSF600077SRSF600078SRSF600079S
- Model NumbersDDPB3D1: GTIN 00763000178376
- Serial Numbers
148 of 148 codes
RSN600151SRSN600345SRSN600582SRSN600650SRSN600668SRSN600669SRSN600670SRSN600672SRSN600694SRSN600699SRSN600851SRSN600858SRSN600861SRSN600876SRSN600880SRSN600922SRSN600961SRSN600963SRSN601156SRSN601478SRSN601693SRSN601804SRSN601808SRSN601810SRSN601830SRSN601867SRSN601992SRSN601993SRSN602032SRSN602068SRSN602136SRSN602139SRSN602140SRSN602142SRSN602145SRSN602153SRSN602155SRSN602156SRSN602181SRSN602185SRSN602186SRSN602191SRSN602196SRSN602208SRSN602209SRSN602219SRSN602222SRSN602224SRSN602226SRSN602228SRSN602229SRSN602230SRSN602234SRSN602235SRSN602236SRSN602237SRSN602239SRSN602247SRSN602254SRSN602261S
- Serial Numbers
138 of 138 codes
RSN600014SRSN600015SRSN600016SRSN600019SRSN600021SRSN600022SRSN600023SRSN600067SRSN600073SRSN600078SRSN600080SRSN600081SRSN600082SRSN600084SRSN600085SRSN600086SRSN600087SRSN600088SRSN600089SRSN600097SRSN600101SRSN600227SRSN600228SRSN600229SRSN600232SRSN600242SRSN600245SRSN600254SRSN600256SRSN600259SRSN600260SRSN600261SRSN600263SRSN600271SRSN600275SRSN600285SRSN600286SRSN600287SRSN600288SRSN600289SRSN600311SRSN600323SRSN600326SRSN600562SRSN601010SRSN601127SRSN601178SRSN601222SRSN601331SRSN601344SRSN601370SRSN601406SRSN601410SRSN601696SRSN601697SRSN601712SRSN601713SRSN601714SRSN601726SRSN601728S
- DDPB3D4GTIN 00763000178390
- Serial Numbers
210 of 210 codes
RSO600071SRSO600171SRSO600224SRSO600701SRSO601078SRSO601186SRSO601351SRSO601382SRSO601825SRSO602370SRSO602418SRSO602598SRSO602645SRSO602836SRSO603379SRSO603655SRSO604461SRSO604504SRSO604506SRSO604717SRSO604787SRSO604909SRSO604912SRSO604913SRSO604914SRSO604915SRSO604916SRSO604917SRSO604918SRSO604919SRSO604921SRSO604922SRSO604923SRSO604924SRSO604928SRSO604929SRSO604930SRSO604934SRSO604935SRSO604936SRSO604938SRSO604941SRSO604942SRSO604944SRSO604948SRSO604955SRSO604957SRSO604960SRSO604961SRSO605123SRSO605606SRSO605635SRSO605850SRSO605900SRSO606177SRSO606188SRSO606294SRSO606493SRSO606747SRSO606931S
- Serial Numbers
622 of 622 codes
RSO600006SRSO600007SRSO600010SRSO600011SRSO600012SRSO600014SRSO600015SRSO600017SRSO600018SRSO600020SRSO600021SRSO600022SRSO600023SRSO600024SRSO600025SRSO600026SRSO600027SRSO600028SRSO600029SRSO600031SRSO600032SRSO600033SRSO600034SRSO600035SRSO600036SRSO600039SRSO600040SRSO600041SRSO600042SRSO600043SRSO600045SRSO600046SRSO600047SRSO600048SRSO600049SRSO600050SRSO600051SRSO600053SRSO600054SRSO600055SRSO600062SRSO600064SRSO600067SRSO600068SRSO600069SRSO600070SRSO600072SRSO600073SRSO600074SRSO600075SRSO600076SRSO600175SRSO600276SRSO600277SRSO600278SRSO600279SRSO600280SRSO600281SRSO600283SRSO600284S
- Amount recalled
- 2866 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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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