CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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 CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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 CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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-1752-2023
- 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.