WATCHMAN TruSeal Access System risks air embolism during transseptal procedures
Boston Scientific is recalling the WATCHMAN TruSeal Access System components due to higher risk of air embolism when transseptal procedures are performed without positive pressure ventilation. All 340,185 non-expired units distributed worldwide are affected in this Class I recall.
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 classification requires a minimum severity score of 4. Although no incidents, injuries, or deaths are documented in the source, the serious potential for harm from air embolism during cardiac procedures justifies this classification level.
Plain-English summary
The WATCHMAN TruSeal Access System SGL (Material Number M635TU70010), manufactured by Boston Scientific, is a medical device that provides vascular and transseptal access for Left Atrial Appendage Closure procedures. All non-expired batches totaling 340,185 units distributed worldwide are subject to this Class I recall.
Boston Scientific identified a higher likelihood of air embolism events when transseptal procedures are performed without positive pressure-controlled ventilation. Published literature and clinical data indicate that in percutaneous procedures requiring transseptal access to the left atrium performed under conscious or deep sedation, patients have 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, and partial upper airway collapse.
Positive pressure-controlled ventilation during transseptal procedures helps mitigate the identified risk of air embolism.
The recalled product
- Product
- WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; 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
- air-ingress
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 08714729965701
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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