Accolade Family Pacemakers recall in Canada: battery depletion risk
In plain language
This recall involves Accolade Family Pacemakers, Accolade MRI Pacemakers, VisionST CRT-P, and VisionST X4 CRT-P sold in Canada. They are being recalled because a latent release of hydrogen may cause the battery to deplete faster than expected. If you have one of these devices, contact your healthcare provider for guidance.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Contact your healthcare provider for further instructions.
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Affected products
Accolade Pacemaker
Model: L300 L301 L321
Lot: More than 10 numbers, contact manufacturer.
Accolade MRI Pacemaker
Model: L310 L311 L331
Lot: More than 10 numbers, contact manufacturer.
VisionST CRT-P
Model: U225 U226
Lot: More than 10 numbers, contact manufacturer.
VisionST X4 CRT-P
Model: U228
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Battery depletion risk
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: L300 L301 L321, L310 L311 L331, U225 U226, U228
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?
Battery depletion risk
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Contact your healthcare provider for further instructions.
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. Battery depletion risk
When was this product recalled?
This product was recalled on June 30, 2021.
Is the Accolade brand affected by this recall?
Yes, Accolade products are affected by this recall. This recall involves Accolade Family Pacemakers, Accolade MRI Pacemakers, VisionST CRT-P, and VisionST X4 CRT-P sold in Canada. They are being recalled because a latent release of hydrogen may cause the battery to deplete faster than expected. If you have one of these devices, contact your healthcare provider for guidance.