Reported Jun 28, 2023 · Ongoing
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; 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 DTMA1QQ CLARIA MRI QUAD US DF4Model Number DTMA1QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN CRTD DTMA1QQ CLARIA MRI QUAD US DF4
- Lot Serial Numbers
2,712 of 2,712 codes
RPA210493HRPA222265HRPA231080HRPA238029HRPA220160HRPA224981HRPA226922HRPA226926HRPA226931HRPA226935HRPA226936HRPA231700HRPA231701HRPA231707HRPA231708HRPA231711HRPA235632HRPA235645HRPA235649HRPA240455HRPA240473HRPA240476HRPA240477HRPA214967HRPA219025HRPA220582HRPA224560HRPA229904HRPA230197HRPA232865HRPA239124HRPA240812HRPA240813HRPA240814HRPA240817HRPA240821HRPA240822HRPA240825HRPA240831HRPA240834HRPA240838HRPA220840HRPA225194HRPA233160HRPA242772HRPA222022HRPA222334HRPA226679HRPA228141HRPA228927HRPA229342HRPA229425HRPA240558HRPA241482HRPA242003HRPA242887HRPA240059HRPA240830HRPA242610HRPA242611H
- Amount recalled
- 58706 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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