WATCHMAN TruSeal Access System Class I Recall: Air Embolism Risk
Boston Scientific is recalling all batches of the WATCHMAN TruSeal Access System worldwide due to increased risk of air embolism when procedures are performed without 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 classification mandates a score of at least 4. While no illnesses have been reported to date, air embolism is a potentially fatal cardiac complication, and the recall documents a three-fold increased risk under certain anesthetic conditions.
Plain-English summary
Boston Scientific Corporation is recalling all non-expired batches of the WATCHMAN TruSeal Access System DBL (Material Number M635TS70020) worldwide. The device is used to provide vascular and transseptal access for WATCHMAN Left Atrial Appendage Closure Devices during cardiac procedures. A total of 340,185 units are affected.
The company has identified a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. According to clinical data and published literature, patients undergoing transseptal access procedures to the left atrium while under conscious or deep sedation have approximately three times higher risk of negative left atrium pressure and air ingress compared to those receiving positive pressure ventilation. This risk is especially elevated in patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse.
Physicians using this device should ensure positive pressure-controlled ventilation is maintained during procedures. Patients who have had procedures performed with this device should consult their healthcare provider if they experience symptoms of air embolism, including chest pain, difficulty breathing, or neurological symptoms.
The recalled product
- Product
- WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; 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 08714729965749
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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