Boston Scientific WATCHMAN FXD Cardiac Access System Recalled for Air Embolism Risk
Boston Scientific is recalling the WATCHMAN FXD Curve Access System worldwide. The device carries elevated air embolism risk when used during cardiac procedures 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: This is an FDA Class I medical device recall. Per the rubric, FDA Class I recalls never score below 4 (Severe), regardless of reported illnesses. No deaths or injuries are reported in the source, but the device creates significant risk of air embolism in cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling the WATCHMAN FXD Curve Access System (UPN M635TU80010) worldwide. This medical device provides vascular and transseptal access for WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Devices with Delivery Systems. The recall encompasses 340,185 units in all non-expired batches.
Boston Scientific identified a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. Clinical data and published literature, including a U.S. study, show that during percutaneous procedures requiring transseptal left atrial access in patients under conscious or deep sedation, the risk of negative left atrium pressure and air ingress is approximately three times higher. This elevated risk is particularly common in patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse.
This recall affects patients undergoing left atrial appendage closure procedures and healthcare facilities that use this device. It is designated as an FDA Class I recall.
The recalled product
- Product
- WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; 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 00191506013806
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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