WATCHMAN FXD Cardiac Access System Recalled for Air Embolism Risk
Boston Scientific is recalling the WATCHMAN FXD Curve Access System worldwide due to increased risk of air embolism during transseptal cardiac procedures, especially in patients under sedation. The risk occurs without adequate positive pressure-controlled ventilation.
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 medical device recall, which per the rubric criteria never goes below score 4. The source does not report specific cases of patient harm or deaths, preventing a Critical rating. The serious, potentially life-threatening nature of air embolism and the FDA's Class I designation justify the Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling the WATCHMAN FXD Curve Access System worldwide due to an identified risk of air embolism during transseptal cardiac procedures. This vascular access device is used to facilitate placement of WATCHMAN FLX left atrial appendage closure (LAAC) devices. The recall affects all non-expired batches of the device, totaling approximately 340,185 units distributed globally.
Boston Scientific identified that air embolism events are more likely to occur when transseptal access procedures are performed without positive pressure-controlled ventilation. According to published medical literature and clinical data, patients undergoing transseptal procedures to the left atrium under conscious or deep sedation face approximately three times higher risk of negative left atrium pressure and air ingress. This risk is particularly elevated in patients with pre-existing low left atrial pressure, hypovolemia (dehydration), or partial upper airway collapse.
Patients who have had WATCHMAN FLX procedures or are scheduled for these procedures should discuss their individual risk with their healthcare provider. Healthcare providers should ensure that positive pressure-controlled ventilation is maintained during transseptal access procedures and monitor patients carefully for signs of air embolism. Adverse events should be reported to the FDA.
The recalled product
- Product
- WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; 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 00191506013820
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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