Reported Aug 3, 2022 · Ongoing
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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., 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 Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
- Lot codes and dates
- GTIN 00763000178178
- Serial Numbers
RTK601865SRTK601825SRTK601828S
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
This product could cause temporary or reversible health problems — stop using it.
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