Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
This recall is currently active, issued July 28, 2022. It was issued by Medtronic Inc., Cardiac Rhythm And Heart Failure (Crhf).
- Recall Initiated
- November 5, 2020
- Posted
- July 28, 2022
- Recall Number
- Z-1480-2022
- Quantity
- 3 units
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Distribution
US Nationwide distribution in the states of Indiana and CA.
Lot / Code Info
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Root Cause
Process control
Action Taken
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.