Reported Jun 28, 2023 · Ongoing
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4Model Number DTMB2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720695
- Lot Serial numbers
2,714 of 2,714 codes
RPG619037SRPG608482SRPG611787SRPG619305SRPG609628SRPG622247SRPG619130SRPG623603SRPG610818SRPG616992SRPG619816SRPG624535SRPG614089SRPG619704SRPG619714SRPG623002SRPG624602SRPG607260SRPG607434SRPG607977SRPG608232SRPG608831SRPG609415SRPG609836SRPG609911SRPG610009SRPG610345SRPG611061SRPG611302SRPG611328SRPG611598SRPG611600SRPG611606SRPG611666SRPG611667SRPG611668SRPG612610SRPG612884SRPG612885SRPG613206SRPG613239SRPG613578SRPG613655SRPG614353SRPG614407SRPG614439SRPG614898SRPG615028SRPG617792SRPG617839SRPG618125SRPG618648SRPG618809SRPG618811SRPG619226SRPG619228SRPG619555SRPG619776SRPG619888SRPG619890S
- Amount recalled
- 28172 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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