Reported Jun 28, 2023 · Ongoing
CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; 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 DTMB1QQ AMPLIA MRI QUAD US DF4Model Number DTMB1QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720671
- Lot Serial Numbers
2,714 of 2,714 codes
RPE221706HRPE221707HRPE221708HRPE221712HRPE221714HRPE221715HRPE222453HRPE222479HRPE222484HRPE222493HRPE223082HRPE223083HRPE223085HRPE223086HRPE223087HRPE224112HRPE224115HRPE224116HRPE224117HRPE221282HRPE222157HRPE222778HRPE222899HRPE223002HRPE223681HRPE222052HRPE224096HRPE224699HRPE225223HRPE225228HRPE225260HRPE226241HRPE226280HRPE226296HRPE226578HRPE226614HRPE226861HRPE227698HRPE227755HRPE223791HRPE226062HRPE221213HRPE221541HRPE221727HRPE221823HRPE222060HRPE222451HRPE222481HRPE222548HRPE222618HRPE222760HRPE222970HRPE222978HRPE223026HRPE224464HRPE224543HRPE224745HRPE225324HRPE225723HRPE225724H
- Amount recalled
- 10370 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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