Medtronic Inc. 2024-07-03 Health serious FDA
Health · FDA · Recall #FDA-Z-2210-2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator Recall
Issued July 3, 2024 · Medtronic Inc.
In July 2024, Medtronic Inc. recalled the COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
What you should do
- 1 Stop using COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Inc. 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.
- Category
- Health
- Recall date
- July 3, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australi
- Recall number
- FDA-Z-2210-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.