Aurora EV-ICD™ MRI SureScan™
Brand(s)
Last updated
Summary
Product
Aurora EV-ICD™ MRI SureScan™
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Aurora EV-ICD™ MRI SureScan™ | More than 10 numbers, contact manufacturer. | DVEA3E4 |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78459
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