Cardiac Access System Recall: WATCHMAN TruSeal Air Embolism Risk
Boston Scientific recalled the WATCHMAN TruSeal Access System for increased air embolism risk during transseptal procedures without positive pressure ventilation, especially in patients with low left atrial pressure or hypovolemia.
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 minimum severity score of 4 per the recall rubric. Although no reported illnesses or deaths are documented in the source, the risk of air embolism during transseptal procedures is a serious, life-threatening hazard.
Plain-English summary
The WATCHMAN TruSeal Access System ANT, OUS (Material Number M635TS70040) manufactured by Boston Scientific Corporation is being recalled globally. This device is used 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 access to the left atrium with conscious or deep sedation face an approximately three-times higher risk of negative left atrium pressure and air ingress.
The risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse. Patients who have had this device implanted or who are scheduled for procedures using this access system should consult with their healthcare provider about the risks and whether additional precautions such as positive pressure ventilation are appropriate.
The recalled product
- Product
- WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; 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 08714729965756
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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