Cobalt Implantable Cardioverter Defibrillators with recall
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Why was Cobalt Implantable Cardioverter Defibrillators with recalled?
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of Indiana and CA.
- Recall date
- August 3, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)