WATCHMAN™ Access Systems recall in Canada: Performance issue
In plain language
This recall involves WATCHMAN™ Access Systems sold in Canada. It's being recalled because of a performance issue related to the risk of air embolism during procedures. Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer for additional information.
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Affected products
WATCHMAN™ TruSeal™ Access System
Model: M635TU70010, M635TU70020, M635TU70040
Lot: Not applicable.
WATCHMAN FXD Curve™ Access System
Model: M635TU80010, M635TU80020
Lot: Not applicable.
WATCHMAN TruSteer™ Access System
Model: M635TU90050
Lot: Not applicable.
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: M635TU70010, M635TU70020, M635TU70040, M635TU80010, M635TU80020, M635TU90050
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?
This recall involves WATCHMAN™ Access Systems sold in Canada. It's being recalled because of a performance issue related to the risk of air embolism during procedures. Stop using the product and contact the manufacturer for more information.
What should consumers do?
Stop using the product immediately. Contact the manufacturer for 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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on July 30, 2025.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves WATCHMAN™ Access Systems sold in Canada. It's being recalled because of a performance issue related to the risk of air embolism during procedures. Stop using the product and contact the manufacturer for more information.