Medical device recall: WATCHMAN TruSeal Access System air embolism risk
Boston Scientific is recalling the WATCHMAN TruSeal Access System due to increased risk of air embolism when transseptal procedures are performed without positive pressure 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 classification with serious hazard (air embolism in cardiac transseptal procedures) justifies Severe rating. Per the rubric, FDA Class I recalls score at minimum 4, regardless of reported illnesses.
Plain-English summary
Boston Scientific is recalling the WATCHMAN TruSeal Access System DBL (Material Number M635TU70020) worldwide. The device provides vascular and transseptal access for WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
The recall was initiated due to a higher likelihood of air embolism events when transseptal procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, patients undergoing percutaneous transseptal access 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 especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse.
All non-expired batches are affected, accounting for 340,185 units total (GTIN 08714729965718). Patients and healthcare providers should review the recall notice and Boston Scientific's recommendations for procedural protocols to minimize air embolism risk during transseptal access procedures.
The recalled product
- Product
- WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; 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 08714729965718
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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