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An official Health Canada notice concerns Aurora ev-icd™ mri surescan™. 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. Published 2025-11-06.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78459
Official notice
2025-11-06
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Medtronic, Aurora Ev-icd™ Mri Surescan™.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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