Boston Scientific Corporation has recalled 340,185 units of its WATCHMAN TruSeal, FXD Curve, and TruSteer Access Systems because patients may be at an increased risk of air bubbles entering the bloodstream (air embolism) during heart procedures. This issue is most likely to occur when the procedure is performed without specific breathing support (positive pressure-controlled ventilation), particularly under conscious or deep sedation. The recall covers several models used to facilitate the insertion of WATCHMAN Left Atrial Appendage Closure devices. Healthcare providers should stop using these devices and contact the manufacturer or their distributor for instructions on returns or corrections.
Air embolism occurs when air enters the heart and is pumped through the body, which can cause a stroke, heart attack, or even death. Patients are at approximately three times higher risk of this complication when these systems are used without pressure-controlled breathing support, especially if they have low heart pressure or airway obstructions.
Intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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