Reported Jun 28, 2023 · Ongoing
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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 DTMA2QQ CLARIA MRI QUAD OUS DF4Model Number DTMA2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720640
- Lot Serial Numbers
2,714 of 2,714 codes
RPB618471SRPB621777SRPB619798SRPB622872SRPB620883SRPB621725SRPB612828SRPB605719SRPB615701SRPB605409SRPB609214SRPB619400SRPB611888SRPB603955SRPB617094SRPB610684SRPB603737SRPB603739SRPB603852SRPB603887SRPB603889SRPB603892SRPB604013SRPB604131SRPB604133SRPB604139SRPB604469SRPB604482SRPB604483SRPB604484SRPB604496SRPB604508SRPB604545SRPB604692SRPB604694SRPB604731SRPB605760SRPB605763SRPB605930SRPB605982SRPB606024SRPB606084SRPB606117SRPB606124SRPB606125SRPB606136SRPB606189SRPB606190SRPB606192SRPB606492SRPB606657SRPB606773SRPB606838SRPB607008SRPB607012SRPB607049SRPB607332SRPB607709SRPB607752SRPB607793S
- Amount recalled
- 23223 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.