Reported Jun 28, 2023 · Ongoing
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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 DTMC2QQ COMPIA MRI QUAD OUS DF4Model Number DTMC2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720688
- Lot Serial numbers
2,714 of 2,714 codes
RPF622750SRPF618290SRPF616459SRPF619209SRPF620414SRPF613519SRPF617908SRPF607263SRPF605123SRPF606355SRPF607965SRPF607966SRPF607968SRPF607969SRPF610837SRPF612639SRPF613175SRPF613176SRPF614678SRPF616130SRPF616164SRPF616174SRPF616577SRPF616578SRPF617220SRPF617584SRPF617585SRPF617586SRPF619084SRPF619475SRPF619476SRPF619729SRPF609798SRPF609803SRPF609809SRPF610924SRPF610929SRPF610935SRPF610938SRPF610947SRPF614776SRPF614782SRPF618353SRPF618354SRPF618355SRPF618356SRPF618357SRPF618358SRPF618361SRPF618362SRPF608224SRPF608225SRPF611060SRPF614821SRPF616957SRPF617031SRPF618423SRPF618476SRPF619798SRPF620332S
- Amount recalled
- 31884 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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