Recall Z-1480-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2020-11-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-11-05
- Firm location
- Mounds View, MN, United States
Product description
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Reason for recall
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.