CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter… Recall
Issued June 28, 2023 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
In June 2023, Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled the CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter…, 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 a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
What you should do
- 1 Stop using CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter… 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.
Recall details
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Category
- Health
- Recall date
- June 28, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide - Worldwide Distribution
- Recall number
- FDA-Z-1773-2023
- 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 903rd Health recall we've logged in 2023.