Reported Jun 28, 2023 · Ongoing
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; 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 DVEX3E4 EV ICD EV4 PIVOTALModel Number DVEX3E4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000217891
- Lot Serial Numbers
134 of 134 codes
EVS600719SEVS600271SEVS600272SEVS600273SEVS600274SEVS600322SEVS600324SEVS600325SEVS600326SEVS600366SEVS600372SEVS600503SEVS600504SEVS600529SEVS600530SEVS600531SEVS600547SEVS600548SEVS600623SEVS600558SEVS600559SEVS600560SEVS600320SEVS600549SEVS600550SEVS600551SEVS600619SEVS600620SEVS600633SEVS600635SEVS600264SEVS600338SEVS600339SEVS600546SEVS600579SEVS600337SEVS600578SEVS600580SEVS600303SEVS600304SEVS600305SEVS600306SEVS600307SEVS600308SEVS600319SEVS600332SEVS600333SEVS600335SEVS600340SEVS600373SEVS600375SEVS600376SEVS600377SEVS600378SEVS600381SEVS600485SEVS600486SEVS600496SEVS600498SEVS600532S
- Lot Serial Numbers
156 of 156 codes
EVS600396SEVS600061SEVS600218SEVS600204SEVS600407SEVS600646SEVS600645SEVS600647SEVS600648SEVS600179SEVS600397SEVS600040SEVS600044SEVS600048SEVS600049SEVS600139SEVS600140SEVS600232SEVS600039SEVS600056SEVS600150SEVS600231SEVS600344SEVS600141SEVS600165SEVS600166SEVS600368SEVS600351SEVS600353SEVS600354SEVS600389SEVS600390SEVS600032SEVS600033SEVS600034SEVS600045SEVS600076SEVS600055SEVS600178SEVS600155SEVS600134SEVS600209SEVS600210SEVS600205SEVS600357SEVS600653SEVS600654SEVS600050SEVS600149SEVS600161SEVS600162SEVS600164SEVS600212SEVS600664SEVS600657SEVS600658SEVS600051SEVS600053SEVS600135SEVS600211S
- Amount recalled
- 289 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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