EV ICD Pivotal Clinical Device recall in Canada: risk of undersensing
In plain language
This recall involves the EV ICD Pivotal Clinical Device sold in Canada. It's being recalled because a software issue could lead to undersensing during arrhythmia confirmation. This could delay or stop therapy for the patient. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Contact the manufacturer for more information.
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Affected products
EV ICD Pivotal Clinical Device
Model: DVEX3E4
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Risk of undersensing during arrhythmia confirmation
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: DVEX3E4
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?
Risk of undersensing during arrhythmia confirmation
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Contact the manufacturer for more 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. Risk of undersensing during arrhythmia confirmation
When was this product recalled?
This product was recalled on September 15, 2020.