Reported Jun 28, 2023 · Ongoing
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; 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-VR DVMC3D4 EVERA MRI S DF4 GLOBModel Number DVMC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720596
- Lot Serial Numbers
785 of 785 codes
PMZ618802SPMZ616324SPMZ616325SPMZ618783SPMZ614007SPMZ616319SPMZ616311SPMZ616317SPMZ616329SPMZ614015SPMZ614036SPMZ616320SPMZ613982SPMZ615518SPMZ616318SPMZ616327SPMZ618780SPMZ618807SPMZ618813SPMZ616312SPMZ616323SPMZ618796SPMZ619084SPMZ618785SPMZ616326SPMZ618798SPMZ614044SPMZ612017SPMZ612853SPMZ613328SPMZ613097SPMZ614065SPMZ614046SPMZ613063SPMZ613316SPMZ614003SPMZ614010SPMZ614033SPMZ614097SPMZ613087SPMZ613201SPMZ614058SPMZ614099SPMZ613212SPMZ613219SPMZ613207SPMZ613206SPMZ613318SPMZ613962SPMZ614002SPMZ613216SPMZ613313SPMZ613073SPMZ613077SPMZ613079SPMZ613082SPMZ613998SPMZ613999SPMZ614000SPMZ614083S
- Lot Serial Numbers
1,926 of 1,926 codes
PMZ613852SPMZ626217SPMZ631682SPMZ628887SPMZ628505SPMZ629326SPMZ626699SPMZ630041SPMZ626064SPMZ617413SPMZ617414SPMZ617415SPMZ617419SPMZ613599SPMZ626477SPMZ629282SPMZ631041SPMZ631723SPMZ631845SPMZ620505SPMZ621618SPMZ628726SPMZ631558SPMZ630526SPMZ612915SPMZ616351SPMZ618065SPMZ618073SPMZ619243SPMZ621226SPMZ621445SPMZ621801SPMZ622087SPMZ625231SPMZ625232SPMZ625545SPMZ626143SPMZ626144SPMZ626145SPMZ626146SPMZ626493SPMZ627647SPMZ628615SPMZ629341SPMZ629345SPMZ629894SPMZ630770SPMZ631846SPMZ627361SPMZ626259SPMZ631961SPMZ622640SPMZ624582SPMZ626196SPMZ627504SPMZ629469SPMZ629470SPMZ629527SPMZ629645SPMZ629697S
- Amount recalled
- 25058
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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