Reported Jun 28, 2023 · Ongoing
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; 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?
ICD COBALT XT DR MRI IS1 DF4Model Number DDPA2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178345
- Lot Serial Numbers
2,714 of 2,714 codes
RSM612933SRSM612934SRSM612935SRSM621211SRSM604622SRSM604623SRSM608882SRSM621210SRSM621212SRSM612673SRSM609800SRSM610899SRSM619550SRSM620275SRSM620130SRSM615997SRSM619083SRSM623383SRSM623721SRSM610958SRSM616552SRSM614351SRSM618224SRSM604877SRSM612655SRSM612656SRSM612657SRSM612659SRSM621000SRSM621003SRSM621005SRSM608749SRSM608750SRSM608751SRSM608752SRSM610434SRSM610435SRSM620999SRSM621001SRSM621004SRSM617554SRSM617555SRSM617556SRSM617558SRSM617559SRSM617557SRSM613882SRSM614841SRSM615782SRSM615936SRSM616172SRSM616444SRSM619209SRSM619289SRSM619651SRSM619896SRSM620690SRSM600889SRSM604260SRSM605557S
- Amount recalled
- 22,114 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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