Boston Scientific recalls WATCHMAN TruSteer Access System (UPN M635TU90050) due to higher risk of air embolism during procedures without positive pressure ventilation. Affected patients may have increased 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 its WATCHMAN TruSteer Access System for a higher risk of air embolism during procedures without positive pressure ventilation. This risk is especially high for patients with low left atrial pressure, hypovolemia, or partial upper airway collapse.
The device can cause negative left atrium pressure during procedures without positive pressure ventilation, leading to air entering the bloodstream. This risk is higher for patients with pre-existing low left atrial pressure, hypovolemia, or partial upper airway collapse.
Patients undergoing procedures with this device, particularly those with low left atrial pressure, hypovolemia, or partial upper airway collapse. Medical professionals using the device for transseptal access procedures.
The WATCHMAN TruSteer Access System with Material Number (UPN) M635TU90050. This device is sold in the U.S. and includes all non-expired batches.
Identify the Material Number (UPN) M635TU90050 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 low left atrial pressure, hypovolemia, or partial upper airway collapse during procedures.
The recall does not specify a remedy, so contact Boston Scientific directly 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-2436-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2436-2025 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.
