WATCHMAN TruSeal Access System recalled for air embolism risk
Boston Scientific is recalling WATCHMAN TruSeal Access System devices worldwide due to increased air embolism risk when procedures are 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 medical device recall. Although air embolism is a potentially serious hazard, the source text reports no actual illnesses or deaths; risk estimates are based on published literature and clinical vulnerability factors.
Plain-English summary
Boston Scientific is recalling 340,185 WATCHMAN TruSeal Access System units (all non-expired batches) distributed worldwide. This medical device is designed to provide vascular and transseptal access during left atrial appendage closure procedures.
Boston Scientific identified a higher likelihood of air embolism events when these procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, patients undergoing transseptal procedures without positive pressure-controlled ventilation—particularly when conscious or deep sedation is used—have approximately three times the risk of negative left atrium pressure and air ingress. The risk is especially elevated in patients with pre-existing low left atrial pressure, low blood volume (hypovolemia), or partial upper airway collapse.
Healthcare providers should review the clinical risk data and implement appropriate ventilation management protocols when using this access system. Patients who have received this device or are scheduled for procedures using this system should consult with their healthcare team regarding the risk and available precautions.
The recalled product
- Product
- WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure 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 08714729965732
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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