WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WAT
Sold At: Boston Scientific Corporation(Worldwide.)
Recall #: FDA-DEVICE-Z-2435-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- GTIN 00191506013813, ALL NON-EXPIRED BATCHES
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Summary
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 to do next
- 1URGENT: Stop using this product immediately - serious health hazard
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Boston Scientific Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.