Reported Jun 28, 2023 · Ongoing
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; 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 CROME HF MRI IS1 DF4Model Number DTPC2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178291
- Lot Serial numbers
172 of 172 codes
RTW600585SRTW600307SRTW600091SRTW600313SRTW600121SRTW600342SRTW600596SRTW600074SRTW600144SRTW600102SRTW600319SRTW600578SRTW600346SRTW600277SRTW600309SRTW600581SRTW600098SRTW600118SRTW600119SRTW600123SRTW600133SRTW600138SRTW600159SRTW600168SRTW600205SRTW600052SRTW600067SRTW600217SRTW600333SRTW600592SRTW600059SRTW600151SRTW600169SRTW600196SRTW600229SRTW600304SRTW600306SRTW600223SRTW600062SRTW600171SRTW600049SRTW600057SRTW600126SRTW600130SRTW600153SRTW600158SRTW600163SRTW600181SRTW600182SRTW600188SRTW600204SRTW600211SRTW600230SRTW600240SRTW600245SRTW600247SRTW600249SRTW600250SRTW600317SRTW600323S
- Lot Serial Numbers
305 of 305 codes
RTW600542SRTW600770SRTW600943SRTW600680SRTW600805SRTW600918SRTW600611SRTW600681SRTW600688SRTW600782SRTW600635SRTW600614SRTW600653SRTW600913SRTW600484SRTW600716SRTW600405SRTW600413SRTW600721SRTW600804SRTW600744SRTW600404SRTW600496SRTW600535SRTW600505SRTW600774SRTW600888SRTW600494SRTW600526SRTW600557SRTW600335SRTW600497SRTW600521SRTW600882SRTW600486SRTW600540SRTW600603SRTW600407SRTW600500SRTW600522SRTW600608SRTW600797SRTW600038SRTW600321SRTW600410SRTW600510SRTW600397SRTW600852SRTW600536SRTW600684SRTW600691SRTW600740SRTW600545SRTW600550SRTW600742SRTW600750SRTW600441SRTW600731SRTW600493SRTW600415S
- Amount recalled
- 476 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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