Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices 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 a medical device used during endoscopic procedures, particularly for papillotomy. These devices enable precise cutting and access to the biliary duct using high-frequency current.
Improper thermoforming of the device can lead to deformation, which may compromise its performance during critical medical procedures. This raises the risk of ineffective treatment or patient harm.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act swiftly to avoid using potentially compromised devices, ensuring safety during medical procedures.
The model number can typically be found on the packaging or directly on the device.
Expect a processing time of approximately 4-6 weeks for refunds or replacements after returning the device.
Document all communications regarding the recall, including phone calls and letters, and keep a copy of the return shipment receipt.
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number: KD-401Q-0730. It is designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The affected units were distributed worldwide, including across multiple U.S. states.
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