Reported Jun 28, 2023 · Ongoing
CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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 DTMA2D4 CLARIA MRI OUS DF4Model Number DTMA2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720664
- Lot Serial Numbers
2,714 of 2,714 codes
RPD605666SRPD602978SRPD602979SRPD603034SRPD604592SRPD601674SRPD603271SRPD604163SRPD605225SRPD604970SRPD601851SRPD602346SRPD602637SRPD603019SRPD605081SRPD605207SRPD604558SRPD604927SRPD604980SRPD601671SRPD601672SRPD601677SRPD601678SRPD602218SRPD602277SRPD602303SRPD602369SRPD602439SRPD602443SRPD602581SRPD602724SRPD602728SRPD602781SRPD602793SRPD602910SRPD602940SRPD603033SRPD603173SRPD603180SRPD603254SRPD603677SRPD603733SRPD603756SRPD603966SRPD603967SRPD604091SRPD604124SRPD604201SRPD604897SRPD605386SRPD605444SRPD605446SRPD605524SRPD605667SRPD605679SRPD605428SRPD604405SRPD604954SRPD604941SRPD605596S
- Amount recalled
- 4593 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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