Reported Jun 28, 2023 · Ongoing
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; 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 DTMC2D1 COMPIA MRI OUS DF1Model Number DTMC2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837652
- Lot Serial Numbers
2,714 of 2,714 codes
RPR605458SRPR606698SRPR605664SRPR602262SRPR601954SRPR602352SRPR602691SRPR602236SRPR601128SRPR601184SRPR601760SRPR603209SRPR603275SRPR603699SRPR605742SRPR605761SRPR605767SRPR605779SRPR605784SRPR605787SRPR605804SRPR605808SRPR605811SRPR605818SRPR606116SRPR606117SRPR606122SRPR606123SRPR606127SRPR606128SRPR606138SRPR606140SRPR606272SRPR606276SRPR606278SRPR606279SRPR606285SRPR606289SRPR607179SRPR607180SRPR607181SRPR607182SRPR607183SRPR607184SRPR607185SRPR607187SRPR607188SRPR607525SRPR606331SRPR607064SRPR607604SRPR607373SRPR604676SRPR605390SRPR605391SRPR607439SRPR602589SRPR602608SRPR602612SRPR602645S
- Amount recalled
- 10197 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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