WATCHMAN TruSeal Access System recalled for air embolism risk in cardiac procedures
Boston Scientific is recalling the WATCHMAN TruSeal Access System for risk of air embolism during cardiac procedures. The device increases air ingress risk when procedures lack positive pressure-controlled ventilation, particularly under conscious or deep sedation.
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 for air embolism risk in cardiac transseptal procedures. Per the rubric, FDA Class I classifications require a minimum severity score of 4.
Plain-English summary
Boston Scientific Corporation is recalling the WATCHMAN TruSeal Access System ANT (Material Number M635TU70040) due to an increased risk of air embolism during cardiac procedures. This device is used to provide vascular and transseptal access for WATCHMAN Left Atrial Appendage Closure Devices and their delivery systems. All non-expired batches worldwide are affected, totaling 340,185 units.
The recall addresses a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, patients undergoing transseptal access to the left atrium under conscious or deep sedation face approximately three times higher risk of developing negative left atrial pressure, which allows air to enter the heart. This risk is especially elevated in patients with pre-existing low left atrial pressure, low blood volume, or partial upper airway collapse.
Patients who have had or are scheduled to have procedures using this device should be aware of the increased air embolism risk. Those with concerns should discuss the recall with their healthcare provider.
The recalled product
- Product
- WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; 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 08714729965725
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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