Boston Scientific recalls WATCHMAN TruSeal Access System SGL for higher air embolism risk 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 TruSeal Access System SGL for a higher risk of air embolism during procedures without positive pressure ventilation. This risk is especially concerning for patients with low left atrial pressure, hypovolemia, or partial upper airway collapse.
The device can cause air to enter the bloodstream during procedures when positive pressure ventilation is not used. This risk increases significantly for patients who already have low left atrial pressure, are hypovolemic, or have partial upper airway collapse.
Patients undergoing cardiac procedures with this device, particularly those with low left atrial pressure, hypovolemia, or partial upper airway collapse. Healthcare providers performing the procedures are most at risk.
The product has Material Number (UPN) M635TS70010. It was sold with GTIN 08714729965732 and all non-expired batches.
Look for Material Number (UPN) M635TS70010 on the device or packaging.
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.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2426-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2426-2025 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.
