Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow recall instructions.
Devices which did not undergo thermoforming could deform and lose performance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The Disposable Triple Lumen Sphincterotome is used in medical procedures involving the biliary and pancreatic ducts. It is designed to facilitate papillotomy using high-frequency current.
The failure of the device to undergo proper thermoforming may compromise its structural integrity, leading to deformation and performance issues during use.
This recall is not part of a broader industry pattern.
The recall could disrupt medical procedures where the device was intended to be used, posing safety concerns that require immediate action.
Model numbers and UDI-DI numbers can typically be found on the packaging of the device or on the device label itself.
Refund processing may take 4-6 weeks once the returned device is received.
Keep all documentation related to the recall, including receipts, correspondence, and photos of the device.
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-431Q-0720. It was distributed globally, including 7,501 units in the U.S. The devices were sold through various healthcare providers.
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