Reported Jun 28, 2023 · Ongoing
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; 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 DTMA1D4 CLARIA MRI US DF4Model Number DTMA1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720657
- Lot Serial Numbers
2,714 of 2,714 codes
RPC203306HRPC205335HRPC207546HRPC210227HRPC205865HRPC205916HRPC205937HRPC206296HRPC206416HRPC206665HRPC207309HRPC207864HRPC208393HRPC209253HRPC209691HRPC209707HRPC209745HRPC209762HRPC209847HRPC209918HRPC209843HRPC203399HRPC204295HRPC202725HRPC207338HRPC204122HRPC210083HRPC207179HRPC207493HRPC207715HRPC208839HRPC210208HRPC210209HRPC210279HRPC202502HRPC206685HRPC207835HRPC202337HRPC203913HRPC206604HRPC206605HRPC206608HRPC206609HRPC207319HRPC207608HRPC209946HRPC207476HRPC208004HRPC205236HRPC207257HRPC202491HRPC202610HRPC203628HRPC203989HRPC204238HRPC204412HRPC204523HRPC205585HRPC210162HRPC202353H
- Amount recalled
- 12291 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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