ACCOLADE™ and VISIONIST™ Pacemakers recall in Canada: performance issue
In plain language
This recall involves ACCOLADE™ and VISIONIST™ pacemakers sold in Canada. They are being recalled due to a performance issue that may cause them to enter safety mode. Contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer if you require additional information.
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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.
VISIONIST™ CRT-P
Model: U225, U226
Lot: More than 10 numbers, contact manufacturer.
VISIONIST™ X4 Crt-P
Model: U228
Lot: More than 10 numbers, contact manufacturer.
ESSENTIO Pacemaker
Model: L100, L101, L121
Lot: More than 10 numbers, contact manufacturer.
ESSENTIO MRI Pacemaker
Model: L110, L111, L131
Lot: More than 10 numbers, contact manufacturer.
PROPONENT Pacemaker
Model: L200, L201, L209, L221
Lot: More than 10 numbers, contact manufacturer.
PROPONENT MRI Pacemaker
Model: L210, L211, L231
Lot: More than 10 numbers, contact manufacturer.
ALTRUA 2 Pacemaker
Model: S701, S702, S722
Lot: More than 10 numbers, contact manufacturer.
VALITUDE CRT-P
Model: U125
Lot: More than 10 numbers, contact manufacturer.
VALITUDE X4 Crt-P
Model: U128
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Performance issue
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: L100, L101, L110, L111, L121, L131, L200, L201, L209, L210, L211, L221, L231, L300, L301, L310, L311, L321, L331, S701, S702, S722, U125, U128, 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?
Performance issue
What should consumers do?
Stop using the product immediately. 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
When was this product recalled?
This product was recalled on August 22, 2025.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves ACCOLADE™ and VISIONIST™ pacemakers sold in Canada. They are being recalled due to a performance issue that may cause them to enter safety mode. Contact the manufacturer for more information.