Recall MonitorHealth ProductsType I recall
WATCHMAN™ Access Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: WATCHMAN™ Access Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| WATCHMAN™ TruSeal™ Access System | Not applicable. | M635TU70020 |
| WATCHMAN™ TruSeal™ Access System | Not applicable. | M635TU70010 |
| WATCHMAN™ TruSeal™ Access System | Not applicable. | M635TU70040 |
| WATCHMAN FXD Curve™ Access System | Not applicable. | M635TU80020 |
| WATCHMAN FXD Curve™ Access System | Not applicable. | M635TU80010 |
| WATCHMAN TruSteer™ Access System | Not applicable. | M635TU90050 |
Issue
Boston Scientific is initiating an advisory to inform customers on the important information related to the risk of air embolism during WATCHMAN™ procedures. Product is not being recalled. Recall start date: July 29, 2025