Boston Scientific recalls WATCHMAN FXD Curve Access System (UPN M635TS80020) 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 entry.
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 (UPN M635TS80020) because it can cause air embolisms during procedures without proper ventilation. This risk is higher for patients with low left atrial pressure or other medical conditions.
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 or partial airway collapse.
Patients undergoing cardiac procedures with this device may be at risk, especially those with low left atrial pressure or partial upper airway collapse. Medical professionals using the device during procedures without positive pressure ventilation are most affected.
Look for the product name 'WATCHMAN FXD Curve Access Sys Dbl, OUS' with Material Number (UPN) M635TS80020. The device was sold with GTIN 00191506013837 and all non-expired batches.
Identify the product by checking the Material Number (UPN) M635TS80020 on the device packaging or label.
The device is not safe to use without positive pressure ventilation during procedures, which increases the risk of air embolism.
Patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse are most at risk during procedures without positive pressure ventilation.
Check for the Material Number (UPN) M635TS80020 on the device packaging or label. The device was sold with GTIN 00191506013837 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-2430-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2430-2025 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.
