Reported Jun 28, 2023 · Ongoing
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; 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-DR DDMB1D4 EVERA MRI XT IS-1/DF4 USModel Number DDMB1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720497
- Lot Serial Numbers
2,714 of 2,714 codes
PFZ236436HPFZ242339HPFZ247708HPFZ247891HPFZ250783HPFZ252117HPFZ259560HPFZ265053HPFZ271895HPFZ248688HPFZ254957HPFZ260373HPFZ273832HPFZ244136HPFZ245315HPFZ264212HPFZ271087HPFZ273388HPFZ238454HPFZ242886HPFZ245032HPFZ245482HPFZ251539HPFZ251620HPFZ254361HPFZ256071HPFZ258481HPFZ259582HPFZ261497HPFZ263430HPFZ264999HPFZ268418HPFZ269828HPFZ274151HPFZ236422HPFZ239293HPFZ240140HPFZ242722HPFZ244519HPFZ244850HPFZ246467HPFZ247093HPFZ248638HPFZ250072HPFZ250429HPFZ251666HPFZ263854HPFZ268573HPFZ268973HPFZ240263HPFZ242174HPFZ247965HPFZ263650HPFZ268685HPFZ270530HPFZ240280HPFZ240282HPFZ240283HPFZ240284HPFZ240285H
- Amount recalled
- 61,404 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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