Reported Jun 28, 2023 · Ongoing
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; 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 DTMA1D1 CLARIA MRI US DF1Model Number DTMA1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837676
- Lot Serial Numbers
2,714 of 2,714 codes
RPT208454HRPT211000HRPT208258HRPT211071HRPT211077HRPT210886HRPT209224HRPT211338HRPT211343HRPT211344HRPT211347HRPT208864HRPT210392HRPT204063HRPT207540HRPT210779HRPT211477HRPT210662HRPT203810HRPT204233HRPT210695HRPT204352HRPT204713HRPT205727HRPT208222HRPT208507HRPT210829HRPT211217HRPT206139HRPT207062HRPT210688HRPT210917HRPT203993HRPT205235HRPT205768HRPT206518HRPT206833HRPT209343HRPT209843HRPT205560HRPT206519HRPT210915HRPT210978HRPT207320HRPT204196HRPT205788HRPT207588HRPT209206HRPT209796HRPT210253HRPT210444HRPT210700HRPT211542HRPT211685HRPT205575HRPT205841HRPT207926HRPT204420HRPT205180HRPT204120H
- Amount recalled
- 11794 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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