Reported Jun 28, 2023 · Ongoing
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; 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 DTMA1Q1 CLARIA MRI QUAD US DF1Model Number DTMA1Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837669
- Lot Serial numbers
2,714 of 2,714 codes
RPS205974HRPS208665HRPS206712HRPS207744HRPS205038HRPS205791HRPS206225HRPS208216HRPS206084HRPS203804HRPS208198HRPS208245HRPS205937HRPS205565HRPS206114HRPS206723HRPS206730HRPS206733HRPS206734HRPS206754HRPS207303HRPS207318HRPS207338HRPS207399HRPS207703HRPS207711HRPS207722HRPS208049HRPS208505HRPS208646HRPS208679HRPS205303HRPS205918HRPS203315HRPS204385HRPS205650HRPS202760HRPS203013HRPS203034HRPS203256HRPS203610HRPS205372HRPS206383HRPS206771HRPS207603HRPS207933HRPS208110HRPS208492HRPS204009HRPS202981HRPS207563HRPS208546HRPS202245HRPS203960HRPS204342HRPS204357HRPS205958HRPS207822HRPS207840HRPS207922H
- Amount recalled
- 8602 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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