Pacemaker recall in Canada: May cause pre-syncope or syncope
In plain language
This recall involves ACCOLADE and VISIONIST pacemakers sold in Canada. They are being recalled because an intermittent signal issue may cause pre-syncope or syncope. 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.
- Return, repair, or dispose of it as instructed.
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Affected products
ACCOLADE PACEMAKER
Model: L300, L301, L321
Lot: Not applicable
ACCOLADE MRI PACEMAKER
Model: L310, L311, L331
Lot: Not applicable
VISIONIST CRT-P
Model: U225
Lot: Not applicable
VISIONIST X4 CRT-P
Model: U228
Lot: Not applicable
Why this matters
May cause pre-syncope or syncope
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: Not applicable
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: L300, L301, L310, L311, L321, L331, U225, 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?
May cause pre-syncope or syncope
What should consumers do?
Stop using the product immediately. Check model numbers. Return, repair, or dispose of it as instructed.
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. May cause pre-syncope or syncope
When was this product recalled?
This product was recalled on January 29, 2018.