Boston Scientific recalls WATCHMAN TruSeal Access System DBL devices due to increased risk of air embolism during procedures without positive pressure ventilation. Affected units have specific material numbers and batch codes.
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Boston Scientific is recalling the WATCHMAN TruSeal Access System DBL devices because they may cause air embolisms during certain medical procedures without proper ventilation. This risk is higher for patients with specific health conditions like low blood volume or airway issues.
The device can create negative pressure in the left atrium during procedures without positive pressure ventilation, allowing air to enter the bloodstream. This risk is higher for patients with low blood volume or airway collapse.
Patients undergoing cardiac procedures with this device are most at risk, particularly those with low blood volume or airway collapse. Medical professionals using the device during procedures without positive pressure ventilation are also affected.
Check for the material number M635TU70020 on the device packaging. The product was sold in the U.S. with GTIN 08714729965718 and all non-expired batches.
Look for the material number M635TU70020 on the device packaging to confirm if it's affected.
Boston Scientific identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.
Patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse are at higher risk during procedures without positive pressure ventilation.
Check for the material number M635TU70020 on the device packaging. The product was sold in the U.S. with GTIN 08714729965718 and all non-expired batches.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2432-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2432-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
