Z-2431-2025 Class I Ongoing
FDA device recall Z-2431-2025 was initiated by Boston Scientific Corporation on Jul 29, 2025 and is designated Class I. Reason for recall: 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… The recall status is ongoing. Affected quantity: 340185 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 10, 2025
- Initiation Date
- Jul 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340185 units in total
Product Description
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason for Recall
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.
Distribution Pattern
Worldwide.
Code Information
GTIN 08714729965701, ALL NON-EXPIRED BATCHES
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2431-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026