Reported Aug 17, 2022 · Ongoing
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR…
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 XT VR ICD
- Model Numbers
DVPA2D1DVPA2D4b. Cobalt XT DR ICD
- Model Numbers
DDPA2D1DDPA2D4
- Lot codes and dates
- a
- Model NumbersDVPA2D1: GTIN 00763000178451
- Serial Numbers
106 of 106 codes
RSC600237SRSC600256SRSC600277SRSC600327SRSC600419SRSC601038SRSC601061SRSC601065SRSC601084SRSC601126SRSC601134SRSC601138SRSC601158SRSC601159SRSC601175SRSC601193SRSC601209SRSC601210SRSC601213SRSC601214SRSC601217SRSC601226SRSC601242SRSC601244SRSC601249SRSC601313SRSC601314SRSC601315SRSC601317SRSC601323SRSC601330SRSC601332SRSC601337SRSC601341SRSC601342SRSC601346SRSC601349SRSC601354SRSC601358SRSC601370SRSC601372SRSC601377SRSC601379SRSC601397SRSC601402SRSC601411SRSC601420SRSC601422SRSC601438SRSC601441SRSC601446SRSC601453SRSC601467SRSC601473SRSC601476SRSC601486SRSC601493SRSC601494SRSC601500SRSC601506S
- Serial Numbers
328 of 328 codes
RSC600021SRSC600025SRSC600029SRSC600031SRSC600037SRSC600053SRSC600056SRSC600059SRSC600062SRSC600063SRSC600077SRSC600223SRSC600227SRSC600309SRSC600315SRSC600403SRSC600405SRSC600410SRSC600459SRSC600460SRSC600463SRSC600469SRSC600479SRSC600509SRSC600518SRSC600523SRSC600524SRSC600525SRSC600526SRSC600529SRSC600538SRSC600540SRSC600542SRSC600543SRSC600554SRSC600555SRSC600560SRSC600562SRSC600564SRSC600569SRSC600571SRSC600572SRSC600573SRSC600575SRSC600577SRSC600578SRSC600581SRSC600586SRSC600588SRSC600598SRSC600599SRSC600606SRSC600610SRSC600613SRSC600616SRSC600618SRSC600619SRSC600620SRSC600621SRSC600670S
- Serial Numbers
139 of 139 codes
RSC600057SRSC600067SRSC600068SRSC600070SRSC600072SRSC600073SRSC600076SRSC600078SRSC600083SRSC600088SRSC600089SRSC600090SRSC600092SRSC600094SRSC600095SRSC600097SRSC600101SRSC600102SRSC600104SRSC600105SRSC600106SRSC600107SRSC600108SRSC600109SRSC600114SRSC600117SRSC600119SRSC600122SRSC600124SRSC600266SRSC600439SRSC600454SRSC600456SRSC600457SRSC600458SRSC600522SRSC600527SRSC600528SRSC600531SRSC600532SRSC600533SRSC600535SRSC600537SRSC600541SRSC600546SRSC600556SRSC600557SRSC600558SRSC600561SRSC600563SRSC600565SRSC600566SRSC600567SRSC600570SRSC600574SRSC600576SRSC600582SRSC600584SRSC600587SRSC600590S
- Serial NumbersRSC601291S
- RSC601741S DVPA2D4GTIN 00763000178468
- Serial Numbers
RSD600321SRSD600325SRSD601337SRSD602358SRSD602590SRSD602748SRSD602794SRSD602910SRSD603138SRSD603280SRSD603519SRSD603660SRSD603697SRSD603727SRSD603739SRSD603753SRSD603762SRSD603815SRSD603997SRSD604003SRSD604056SRSD604057SRSD604071SRSD604074SRSD604075SRSD604076SRSD604080SRSD604183SRSD604184SRSD604192SRSD604202SRSD604205SRSD604221SRSD604222SRSD604230SRSD604231SRSD604245SRSD604247SRSD604311SRSD604324SRSD604327SGTIN 00763000178482
- Serial Numbers
1,114 of 1,114 codes
RSD600016SRSD600017SRSD600018SRSD600019SRSD600022SRSD600023SRSD600030SRSD600031SRSD600038SRSD600041SRSD600042SRSD600043SRSD600044SRSD600046SRSD600047SRSD600048SRSD600061SRSD600062SRSD600063SRSD600064SRSD600087SRSD600090SRSD600091SRSD600093SRSD600094SRSD600095SRSD600099SRSD600163SRSD600168SRSD600170SRSD600171SRSD600172SRSD600174SRSD600175SRSD600176SRSD600177SRSD600178SRSD600179SRSD600180SRSD600181SRSD600182SRSD600183SRSD600295SRSD600628SRSD600633SRSD600635SRSD600636SRSD600639SRSD600644SRSD600646SRSD600647SRSD600652SRSD600679SRSD600713SRSD600717SRSD600720SRSD600721SRSD600722SRSD600727SRSD600733S
- Serial Numbers
300 of 300 codes
RSD600050SRSD600051SRSD600052SRSD600053SRSD600054SRSD600055SRSD600056SRSD600058SRSD600066SRSD600068SRSD600069SRSD600070SRSD600072SRSD600073SRSD600076SRSD600077SRSD600078SRSD600079SRSD600082SRSD600083SRSD600084SRSD600085SRSD600086SRSD600088SRSD600101SRSD600102SRSD600104SRSD600105SRSD600107SRSD600109SRSD600110SRSD600111SRSD600113SRSD600116SRSD600117SRSD600118SRSD600119SRSD600122SRSD600125SRSD600126SRSD600128SRSD600131SRSD600133SRSD600135SRSD600140SRSD600141SRSD600142SRSD600144SRSD600146SRSD600147SRSD600149SRSD600151SRSD600152SRSD600153SRSD600155SRSD600157SRSD600160SRSD600162SRSD600166SRSD600167S
- Serial Numbers
RSD602523SRSD603425SRSD603492SRSD603950SRSD603971SRSD604109Sb
- Model NumbersDDPA2D1: GTIN 00763000178338
- Serial Numbers
113 of 113 codes
RSL600237SRSL600432SRSL600496SRSL600509SRSL600666SRSL600825SRSL600826SRSL601330SRSL601357SRSL601362SRSL601367SRSL601368SRSL601373SRSL601385SRSL601430SRSL601438SRSL601444SRSL601482SRSL601490SRSL601491SRSL601500SRSL601501SRSL601504SRSL601506SRSL601510SRSL601520SRSL601526SRSL601529SRSL601535SRSL601538SRSL601540SRSL601545SRSL601549SRSL601559SRSL601617SRSL601618SRSL601643SRSL601651SRSL601652SRSL601667SRSL601670SRSL601673SRSL601676SRSL601677SRSL601679SRSL601680SRSL601681SRSL601688SRSL601694SRSL601708SRSL601709SRSL601716SRSL601721SRSL601737SRSL601744SRSL601761SRSL601762SRSL601767SRSL601769SRSL601784S
- Serial Numbers
280 of 280 codes
RSL600037SRSL600042SRSL600043SRSL600044SRSL600063SRSL600064SRSL600066SRSL600069SRSL600077SRSL600082SRSL600083SRSL600107SRSL600124SRSL600158SRSL600170SRSL600183SRSL600408SRSL600450SRSL600696SRSL600805SRSL600807SRSL600812SRSL600813SRSL600815SRSL600819SRSL600822SRSL600833SRSL600840SRSL600846SRSL600868SRSL600869SRSL600874SRSL600875SRSL600878SRSL600882SRSL600884SRSL600894SRSL600896SRSL600901SRSL600906SRSL600910SRSL600922SRSL600930SRSL600940SRSL600951SRSL600955SRSL600958SRSL600963SRSL600972SRSL600981SRSL600993SRSL600998SRSL600999SRSL601004SRSL601005SRSL601006SRSL601007SRSL601008SRSL601009SRSL601010S
- Serial Numbers
253 of 253 codes
RSL600127SRSL600128SRSL600131SRSL600132SRSL600134SRSL600135SRSL600136SRSL600137SRSL600138SRSL600139SRSL600140SRSL600143SRSL600144SRSL600145SRSL600146SRSL600325SRSL600476SRSL600731SRSL600732SRSL600734SRSL600735SRSL600737SRSL600738SRSL600739SRSL600740SRSL600742SRSL600744SRSL600745SRSL600747SRSL600748SRSL600749SRSL600750SRSL600752SRSL600756SRSL600760SRSL600763SRSL600766SRSL600767SRSL600768SRSL600773SRSL600774SRSL600775SRSL600776SRSL600780SRSL600783SRSL600784SRSL600786SRSL600791SRSL600792SRSL600796SRSL600799SRSL600800SRSL600829SRSL600830SRSL600831SRSL600832SRSL600834SRSL600835SRSL600836SRSL600837S
- Amount recalled
- 6884 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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