WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to… Recall
Issued September 10, 2025 · Boston Scientific Corporation
In September 2025, Boston Scientific Corporation recalled the WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
What you should do
- 1 Stop using WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- September 10, 2025
- Units affected
- Not reported
- Sold at
- Worldwide.
- Recall number
- FDA-Z-2431-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.