WATCHMAN™ Access Systems
Brand(s)
Last updated
Summary
Product
WATCHMAN™ Access Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77788
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