Boston Scientific recalls WATCHMAN TruSeal Access System ANT (UPN M635TU70040) due to higher risk of air embolism during procedures without positive pressure ventilation. Affected patients may face increased risk of negative left atrium pressure and air ingress.
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 ANT device because it can cause air embolisms during certain medical procedures. This risk is higher for patients with low left atrial pressure, low blood volume, or partial airway collapse. The recall affects medical devices used in heart procedures.
The device can cause negative pressure in the left atrium during procedures without proper ventilation, allowing air to enter the bloodstream. This risk is higher for patients who already have low blood volume or partial airway collapse.
Patients undergoing heart procedures with this device are most at risk, particularly those with low blood volume or airway issues. Healthcare providers using the device for left atrial appendage closure may also be affected.
Check for the Material Number (UPN) M635TU70040 on the device. The product is used in heart procedures for left atrial appendage closure and is sold with GTIN 08714729965725. All non-expired batches are included in this recall.
Look for the Material Number (UPN) M635TU70040 on the device or packaging.
Boston Scientific identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation, especially for patients with low left atrial pressure or airway issues.
Patients undergoing heart procedures with this device who have low blood volume or partial airway collapse are at higher risk of air entering the bloodstream.
The recalled device has Material Number (UPN) M635TU70040 and is sold with GTIN 08714729965725. All non-expired batches are included in this recall.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2433-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2433-2025 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.
