Official recall record
Aurora EV-ICD™ MRI SureScan™
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-11-06
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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