Boston Scientific recalls WATCHMAN TruSeal Access System ANT, OUS models with UPN M635TS70040 due to higher risk of air embolism during procedures without positive pressure ventilation. Affected patients may have up to three times higher risk of negative left atrium 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 ANT and OUS models with specific material numbers because they can increase the risk of air embolism during certain procedures. This risk is especially high for patients with low left atrial pressure, low blood volume, or partial airway collapse.
The device can create negative pressure in the left atrium during procedures without positive pressure ventilation, which may allow air to enter the bloodstream. This risk is three times higher in patients with low blood volume or airway issues compared to normal cases.
Patients undergoing procedures with this device, particularly those with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse. Medical professionals using the device during procedures with conscious or deep sedation are most at risk.
The device has a Material Number (UPN) M635TS70040. It was sold with GTIN 08714729965756 and includes all non-expired batches. The product is used for vascular and transseptal access with WATCHMAN Left Atrial Appendage Closure Devices.
Look for the Material Number (UPN) M635TS70040 on the device packaging or label.
The device can create negative pressure in the left atrium during procedures without positive pressure ventilation, increasing the risk of air entering the bloodstream. This risk is three times higher in patients with low blood volume or airway issues.
Patients with pre-existing low left atrial pressure, hypovolemia (low blood volume), or partial upper airway collapse are most at risk during procedures with conscious or deep sedation.
The official recall does not specify a fix or remedy; the device is being recalled for potential risk during procedures without positive pressure ventilation.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2428-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2428-2025 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.
