Aurora EV-ICD™ MRI SureScan™ recall in Canada: performance issue
In plain language
This recall involves the Aurora EV-ICD™ MRI SureScan™, a medical device. It's being recalled because a rare sequence of events could delay high-voltage therapy. This delay may impact the device's effectiveness.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Aurora EV-ICD™ MRI SureScan™
Model: DVEA3E4
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Performance issue affecting defibrillation efficacy
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: DVEA3E4
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue affecting defibrillation efficacy
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue affecting defibrillation efficacy
When was this product recalled?
This product was recalled on November 6, 2025.
Is the MEDTRONIC INC. brand affected by this recall?
Yes, MEDTRONIC INC. products are affected by this recall. This recall involves the Aurora EV-ICD™ MRI SureScan™, a medical device. It's being recalled because a rare sequence of events could delay high-voltage therapy. This delay may impact the device's effectiveness.