CanadaAurora EV-ICD MRI SureScan implantable cardioverter-defibrillators (model DVEA3E4; affected lot/serial numbers: more than 10 numbers, contact the manufacturer) are affected. They were recalled because there is a potential for a delayed time to high‑voltage (HV) therapy—six events (delays of 2–17 seconds) were observed among 4,900 implanted devices worldwide, five during controlled defibrillation testing, and such a delay may impact defibrillation efficacy. Contact the manufacturer, Medtronic Inc., for additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: Aurora EV-ICD™ MRI SureScan™; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: DVEA3E4
The hazard
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. Through 2-October-2025, six (6) events (delay of 2-17 seconds) were observed among 4,900 implanted devices worldwide (~0.12%). Five of the six events experienced this behavior during a controlled defibrillation test. While not observed clinically, a delay in HV therapy may impact defibrillation efficacy.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)