Reported Jul 3, 2024 · Ongoing
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
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. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
- Lot codes and dates
- GTIN00763000711344
- Serial Numbers
RSC604641SRSC604642SRSC604643SRSC604644SRSC604647SRSC604653SRSC604654SRSC604655S
- Amount recalled
- 8 units
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
Why it was recalled
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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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