WATCHMAN FXD Curve Access System Linked to Air Embolism Risk
Boston Scientific is recalling WATCHMAN FXD Curve Access System units due to increased air embolism risk when procedures are performed without positive pressure-controlled ventilation. The recall affects approximately 340,185 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates reasonable probability of serious adverse health consequences or death. No specific illnesses or deaths are reported in the source, but the hazard—air embolism during medical procedures—is inherently serious and life-threatening.
Plain-English summary
Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl (Material Number M635TU80020) intended to provide vascular and transseptal access for WATCHMAN FLX LAAC Devices with Delivery Systems. This recall affects approximately 340,185 units and applies to all non-expired batches distributed worldwide.
The recall was initiated because of a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, patients undergoing transseptal access procedures to the left atrium with conscious or deep sedation face approximately three times higher risk of negative left atrium pressure and air ingress. This risk is especially heightened in patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse.
The FDA has classified this as a Class I recall, indicating the agency's determination that there is a reasonable probability that the use of this device will cause serious adverse health consequences or death.
The recalled product
- Product
- WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- air-embolism
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00191506013813
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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