Boston Scientific recalls WATCHMAN FXD Curve Access System Sgl (UPN M635TU80:10) due to higher risk of air embolism during procedures without positive pressure ventilation. Patients with low left atrial pressure may face increased risk of air entering the bloodstream.
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 its WATCHMAN FXD Curve Access System Sgl device because it can cause air embolisms during certain medical procedures. 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. This negative pressure may allow air to enter the bloodstream, increasing the risk of air embolism. Patients with pre-existing low left atrial pressure or airway issues are at higher risk.
Patients undergoing procedures with this device, especially those with low left atrial pressure, hypovolemia, or partial upper airway collapse. Medical professionals using the device during transseptal access procedures.
The device has a Material Number (UPN) M635TU80010. It was sold in the U.S. with GTIN 00191506013806 across all non-expired batches.
Look for the Material Number (UPN) M635TU80010 on the device packaging or label.
The device is not safe to use without positive pressure ventilation during procedures. Boston Scientific recommends using positive pressure ventilation to reduce air embolism risk.
Patients with low left atrial pressure, hypovolemia, or partial upper airway collapse are at higher risk of air embolism.
Check the device packaging for the Material Number (UPN) M635TU80010 or the GTIN 00191506013806.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2434-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2434-2025 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.
