Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 2022-08-17 Health critical FDA
Health · FDA · Recall #FDA-Z-1485-2022
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers:… Recall
Issued August 17, 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: a. Cobalt XT VR ICD, Model Numbers:…, a critical 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
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
What you should do
- 1 Stop using Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers:… 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 17, 2022
- Units affected
- Not reported
- Sold at
- Worldwide Distribution
- Recall number
- FDA-Z-1485-2022
- 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.