WATCHMAN FXD Curve Access System recalled for air embolism risk
Boston Scientific is recalling the WATCHMAN FXD Curve Access System (340,185 units) due to increased air embolism risk during transseptal heart procedures performed without positive pressure-controlled ventilation, particularly in sedated patients.
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 recall, which mandates a minimum severity score of 4. The hazard—air embolism during cardiac procedures—is serious and can cause stroke or death. While no specific incident reports are provided in the source, the procedural risk is identified based on published literature and clinical data, affecting vulnerable patient populations.
Plain-English summary
Boston Scientific is recalling the WATCHMAN FXD Curve Access System, Material Number M635TS80020, used to provide vascular and transseptal access during WATCHMAN FLX Left Atrial Appendage Closure (LAAC) procedures. All non-expired batches worldwide are affected (approximately 340,185 units).
Boston Scientific identified 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 percutaneous transseptal procedures under conscious or deep sedation have an approximately three-fold higher risk of negative left atrium pressure and air ingress.
Risk is elevated in patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse. Healthcare providers should ensure positive pressure-controlled ventilation is maintained during all transseptal procedures using this device. Patients undergoing these procedures should discuss any concerns with their healthcare team and verify appropriate safety precautions are in place.
The recalled product
- Product
- WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; 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 00191506013837
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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