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Aurora ev-icd™ mri surescan™

Official notice

6 Nov 2025

Last checked

6 Nov 2025

Medium riskHealth Canada
Watch Medtronic

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

78459

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Affected products

Product 1

Affected products - Aurora EV-ICD™ MRI SureScan™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - DVEA3E4

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Medtronic, Aurora Ev-icd™ Mri Surescan™

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Aurora Ev-icd™ Mri Surescan™.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

78459

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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