Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Reported: August 3, 2022 Initiated: November 5, 2020 #Z-1480-2022
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.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 3 units
- Distribution
- US Nationwide distribution in the states of Indiana and CA.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D). Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 3 units.
Why was this product recalled? ▼
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1480-2022.
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