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Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.
Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.