Cardiac access system recalled for air embolism risk
Boston Scientific's WATCHMAN TruSteer Access System is recalled due to increased air embolism risk when procedures use conscious or deep sedation without proper ventilation. Risk is highest in patients with low left atrial pressure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which establishes a minimum severity of Severe. Although no deaths, hospitalizations, or patient injuries are reported in the source, air embolism during cardiac access is a serious, potentially life-threatening hazard.
Plain-English summary
The WATCHMAN TruSteer Access System, a medical device used to provide vascular and transseptal access for WATCHMAN FLX left atrial appendage closure devices, is being recalled by Boston Scientific Corporation. The recall affects all non-expired batches worldwide, impacting approximately 340,185 units.
Boston Scientific identified a higher likelihood of air embolism events when procedures using this system are performed without positive pressure-controlled ventilation. According to published clinical data, patients undergoing transseptal access to the left atrium under conscious or deep sedation face approximately three times the normal risk of negative left atrium pressure and air ingress into the cardiac chamber.
The air embolism risk is especially elevated in patients with pre-existing low left atrial pressure, hypovolemia (reduced blood volume), or partial upper airway collapse. These patient factors can compound the hazard during procedures when proper ventilation protocols are not maintained.
Patients with this device and their physicians should ensure that procedures are performed with appropriate positive pressure ventilation controls in place to reduce the risk of air embolism.
The recalled product
- Product
- WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Access
- Hazard
- air-embolism
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00191506022310
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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