Reported Jun 28, 2023 · Ongoing
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; 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 DTMC2D4 COMPIA MRI OUS DF4Model Number DTMC2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720701
- Lot Serial Numbers
2,714 of 2,714 codes
RPH603922SRPH608147SRPH603531SRPH607413SRPH607373SRPH604394SRPH606758SRPH603572SRPH606941SRPH603152SRPH603203SRPH603999SRPH604021SRPH606976SRPH603841SRPH604928SRPH605779SRPH605780SRPH606559SRPH606577SRPH606694SRPH606731SRPH606795SRPH607014SRPH607015SRPH607016SRPH607157SRPH607244SRPH607443SRPH607748SRPH608114SRPH607674SRPH607675SRPH607677SRPH607681SRPH607688SRPH609399SRPH607884SRPH608003SRPH608138SRPH608464SRPH608655SRPH608676SRPH608835SRPH608853SRPH608950SRPH608952SRPH608958SRPH609021SRPH609279SRPH609280SRPH609281SRPH609282SRPH607432SRPH609308SRPH607753SRPH603849SRPH603912SRPH603913SRPH604139S
- Amount recalled
- 11375 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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