Reported Jun 28, 2023 · Ongoing
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
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?
ICD COBALT XT VR MRI IS1 DF1Model Number DVPA2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178451
- Lot Serial Numbers
1,280 of 1,280 codes
RSC601940SRSC601072SRSC601241SRSC600327SRSC601396SRSC602028SRSC602030SRSC602031SRSC602036SRSC600018SRSC602529SRSC602530SRSC602531SRSC602532SRSC600347SRSC600391SRSC600419SRSC601490SRSC602703SRSC600337SRSC600420SRSC600421SRSC600422SRSC600423SRSC600501SRSC601410SRSC601433SRSC602269SRSC601444SRSC601446SRSC602764SRSC602765SRSC600131SRSC600281SRSC600298SRSC601388SRSC602497SRSC600174SRSC602387SRSC601415SRSC602106SRSC600225SRSC600240SRSC601647SRSC602710SRSC601960SRSC601961SRSC602209SRSC602257SRSC602306SRSC602379SRSC602473SRSC600293SRSC600299SRSC600328SRSC601071SRSC601345SRSC601443SRSC601450SRSC601632S
- Lot Serial Numbers
552 of 552 codes
RSC600586SRSC602533SRSC602040SRSC602046SRSC601929SRSC602659SRSC602177SRSC601786SRSC602799SRSC602094SRSC602921SRSC602910SRSC602780SRSC602175SRSC602508SRSC600971SRSC601569SRSC600921SRSC601548SRSC600077SRSC602272SRSC601738SRSC601779SRSC602280SRSC601770SRSC602893SRSC602894SRSC602895SRSC603045SRSC603051SRSC601301SRSC600958SRSC601007SRSC601267SRSC601814SRSC601286SRSC602471SRSC602896SRSC601055SRSC601921SRSC602969SRSC602987SRSC603037SRSC600021SRSC600794SRSC601268SRSC601271SRSC601299SRSC601661SRSC601736SRSC602273SRSC600538SRSC600893SRSC602916SRSC600894SRSC601584SRSC600789SRSC601304SRSC601565SRSC600053S
- Lot Serial Numbers
170 of 170 codes
RSC600906SRSC600531SRSC600576SRSC600955SRSC600108SRSC600873SRSC600117SRSC601013SRSC600973SRSC600068SRSC600556SRSC600557SRSC600561SRSC600591SRSC600875SRSC600901SRSC600934SRSC600942SRSC600528SRSC600859SRSC600102SRSC600104SRSC600600SRSC600558SRSC601562SRSC602564SRSC601794SRSC600853SRSC600614SRSC601823SRSC600979SRSC600105SRSC601768SRSC600871SRSC600083SRSC601279SRSC600868SRSC601754SRSC600602SRSC600097SRSC600566SRSC600537SRSC600119SRSC600854SRSC600584SRSC600954SRSC600985SRSC600070SRSC600587SRSC600957SRSC600095SRSC600109SRSC600458SRSC600522SRSC600563SRSC600594SRSC600608SRSC600937SRSC600943SRSC600974S
- Amount recalled
- 2000 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and 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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