FDA Recall
Open, Classified
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Recall: Z-1480-2022
·
Initiated November 5, 2020
Recall
- Recall Number
- Z-1480-2022
- Event Number
- 90429
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- FEI Number
- 2182208
- Product Code
- NIK
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 5, 2020
- Posted
- July 28, 2022
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Reason
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Action
On 05-Nov-2020, Medtronic initiated retrieval activities via verbal communication to consignees who were in possession of unused, affected devices according to Medtronic records. Consignees were advised to quarantine all affected devices within their possession. In the United States, a written communication was mailed to two (2) identified consignees on 24-Nov-2020, directing the return of all unused, affected devices.
Distribution
US Nationwide distribution in the states of Indiana and CA.
Quantity
3 units