Reported Jun 28, 2023 · Ongoing
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; 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 MRI IS1 DF4Model Number DTPA2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178130
- Lot Serial Numbers
2,714 of 2,714 codes
RTG605297SRTG605299SRTG600588SRTG601635SRTG601691SRTG601840SRTG601857SRTG602986SRTG601966SRTG601364SRTG601621SRTG600270SRTG600554SRTG601405SRTG601699SRTG601977SRTG605270SRTG600137SRTG600138SRTG600181SRTG600271SRTG600618SRTG600620SRTG600621SRTG600622SRTG600640SRTG601395SRTG601441SRTG601681SRTG601783SRTG601896SRTG601945SRTG601948SRTG602037SRTG602040SRTG602042SRTG602047SRTG602165SRTG602166SRTG602167SRTG602340SRTG605614SRTG602039SRTG602228SRTG602306SRTG602477SRTG605996SRTG605997SRTG604903SRTG600228SRTG600332SRTG601906SRTG602441SRTG605330SRTG605332SRTG605838SRTG601643SRTG606091SRTG600317SRTG600255S
- Amount recalled
- 1914 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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