Boston Scientific recalls WATCHMAN FXD Curve Access System Dbl (UPN M635TU80:0020) 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 a specific type of heart device access system because it can increase the risk of air entering the bloodstream during certain medical procedures. This risk is higher for patients who already have low blood pressure in the left heart chamber or are dehydrated.
The device can create negative pressure in the left heart chamber during procedures, allowing air to enter the bloodstream. This risk is higher for patients who already have low blood pressure in the left heart or are dehydrated.
Patients undergoing heart procedures with this device may be at risk, especially those with low left atrial pressure or dehydration. Medical professionals using the device during procedures without positive pressure ventilation are most affected.
Look for the product name 'WATCHMAN FXD Curve Access System Dbl' with Material Number (UPN) M635TU80020. The device was sold in the U.S. and is part of the WATCHMAN FLX LAAC Devices family.
Verify the Material Number (UPN) M635TU80020 on the device packaging or label.
Discuss with your healthcare provider if you have low left atrial pressure or are dehydrated, as these conditions increase the risk.
The device is safe for most procedures but requires positive pressure ventilation during use to reduce air embolism risk. Patients with low left atrial pressure or dehydration are at higher risk.
Check the Material Number (UPN) M635TU80020 on the device. Consult your doctor if you have low left atrial pressure or are dehydrated.
The official recall does not provide a fix; the remedy is null, meaning no action is required beyond checking the device and consulting your doctor.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2435-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2435-2025 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.
