Reported Jan 31, 2024 · Ongoing
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
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 DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
- Lot codes and dates
UDI/DI 00763000178338Serial Number RSL604096S
- Amount recalled
- 1 device
Where it was sold
- Nationwide
- FL
Why it was recalled
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
This product could cause temporary or reversible health problems — stop using it.
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