Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 2022-08-03 Health serious FDA
Health · FDA · Recall #FDA-Z-1480-2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy… Recall
Issued August 3, 2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
In August 2022, Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled the Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
What you should do
- 1 Stop using Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Category
- Health
- Recall date
- August 3, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of Indiana and CA.
- Recall number
- FDA-Z-1480-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 21 recalls in our database, including 20 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.