Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
FDA device recall Z-1480-2022 · posted 2022-07-28 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Reason for recall
- Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NIK
- Quantity affected
- 3 units
- Distribution
- US Nationwide distribution in the states of Indiana and CA.
- Date initiated
- 2020-11-05
- Date posted
- 2022-07-28
- Location
- Mounds View, MN
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