Reported Jun 28, 2023 · Ongoing
CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; 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 COBALT XT HF QUAD MRI IS4 DF4Model Number DTPA2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178093
- Lot Serial Numbers
2,714 of 2,714 codes
RTC605498SRTC605500SRTC605501SRTC605502SRTC607884SRTC607885SRTC608196SRTC608199SRTC608200SRTC610884SRTC610885SRTC610887SRTC610889SRTC610890SRTC610892SRTC626989SRTC626991SRTC626992SRTC626996SRTC604820SRTC605664SRTC606411SRTC606605SRTC613019SRTC613629SRTC614078SRTC612708SRTC614277SRTC611123SRTC611127SRTC611128SRTC613158SRTC613159SRTC613160SRTC613162SRTC613164SRTC613165SRTC613166SRTC626776SRTC626778SRTC626780SRTC612365SRTC612540SRTC612629SRTC614220SRTC600235SRTC600300SRTC600381SRTC600573SRTC602541SRTC602726SRTC605274SRTC605795SRTC607215SRTC607469SRTC608981SRTC609490SRTC610107SRTC610867SRTC613560S
- Amount recalled
- 27788 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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