Boston Scientific recalls WATCHMAN TruSeal Access System DBL/ous models due to higher risk of air embolism during procedures without positive pressure ventilation, especially in patients with low left atrial pressure.
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 and OUS models because they can cause air embolisms during procedures without proper ventilation. This risk is higher for patients with low left atrial pressure, hypovolemia, or partial airway collapse.
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 who already have low left atrial pressure, low blood volume, or partial airway collapse.
Patients undergoing cardiac procedures with this device, especially those with low left atrial pressure, hypovolemia, or partial upper airway collapse. Healthcare providers using the device during procedures.
The WATCHMAN TruSeal Access System DBL or OUS models with Material Number (UPN) M635TS70020. These were sold with GTIN 08714729965749 and all non-expired batches.
Look for the Material Number (UPN) M635TS70020 on the device packaging or label.
Reach out to Boston Scientific directly for guidance on next steps if you have the recalled device.
The device is not safe without positive pressure ventilation during procedures, especially for patients with low left atrial pressure or airway issues.
Patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse during procedures.
Check the Material Number (UPN) M635TS70020 on the device and contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2427-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2427-2025 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.
