Recall Monitor
Health Products

Aurora EV-ICD™ MRI SureScan™

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Aurora EV-ICD™ MRI SureScan™
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel 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.

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