Olympus Corporation of the Americas recalled 136,037 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients must stop using the devices immediately.
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 Single Use 3-Lumen Sphincterotome V is a medical instrument designed for use in endoscopic procedures, specifically for papillotomy with high-frequency current. Healthcare providers purchase this device to facilitate specific surgical interventions.
The defect arises from the lack of proper thermoforming during manufacturing, which can result in deformation of the device. Such deformation may compromise the device's intended function, posing serious risks during medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face immediate health risks due to the potential for device malfunction. The recall also emphasizes the importance of safety in medical device manufacturing.
The model number and expiration date can typically be found on the device packaging or accompanying documentation.
Expect a refund or replacement processing timeline of about 4-6 weeks after following the recall instructions.
Keep records of your device's model number, purchase documentation, and any correspondence with Olympus regarding the recall.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-0725. The recall includes 9,959 units distributed in the U.S. and 126,078 units internationally.
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