Reported Jun 28, 2023 · Ongoing
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; 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 DTMA2Q1 CLARIA MRI QUAD OUS DF1Model Number DTMA2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837614
- Lot Serial numbers
1,293 of 1,293 codes
RPN602297SRPN602079SRPN601385SRPN601320SRPN601216SRPN601977SRPN602107SRPN600885SRPN601199SRPN600682SRPN601504SRPN601513SRPN601653SRPN601681SRPN602258SRPN600961SRPN600858SRPN600867SRPN600868SRPN600942SRPN601384SRPN601398SRPN601516SRPN601873SRPN601874SRPN602264SRPN602302SRPN602350SRPN602422SRPN602462SRPN602468SRPN602507SRPN601042SRPN601529SRPN602434SRPN601306SRPN601439SRPN602416SRPN601214SRPN601763SRPN601891SRPN600750SRPN601165SRPN600770SRPN601245SRPN602186SRPN602293SRPN600666SRPN600683SRPN601094SRPN601229SRPN601277SRPN601298SRPN601393SRPN601662SRPN602160SRPN600812SRPN601674SRPN602429SRPN600678S
- Lot Serial Numbers
366 of 366 codes
RPN602735SRPN603088SRPN602982SRPN602524SRPN602992SRPN603144SRPN603019SRPN602975SRPN602997SRPN603139SRPN602843SRPN602891SRPN602839SRPN602991SRPN603153SRPN602756SRPN602766SRPN602554SRPN602750SRPN602907SRPN602874SRPN602945SRPN602836SRPN602856SRPN602717SRPN602774SRPN602795SRPN602995SRPN602685SRPN602779SRPN602876SRPN602759SRPN602696SRPN602953SRPN602786SRPN602800SRPN602862SRPN602893SRPN603084SRPN602761SRPN603093SRPN602792SRPN602898SRPN603038SRPN602694SRPN602772SRPN602709SRPN602879SRPN602758SRPN602675SRPN602661SRPN602925SRPN602782SRPN602656SRPN603050SRPN602824SRPN603111SRPN602968SRPN602698SRPN602699S
- Amount recalled
- 1658 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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