Olympus Corporation of the Americas recalled 33,433 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices that did not undergo thermoforming may deform and lose performance, posing a high risk to patients. Healthcare providers and patients should stop using the device 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 device used with endoscopes for papillotomy procedures. It is designed to utilize high-frequency current for surgical interventions.
The hazard arises when devices that did not undergo thermoforming deform, leading to potential performance issues during critical medical procedures.
This recall is not part of a broader industry pattern.
Consumers should stop using the recalled device immediately to avoid risks associated with potential deformation and compromised performance.
The model number can typically be found on the device packaging or the device itself.
Expect a refund or replacement to be processed within 4-6 weeks after the return of the product.
Keep records of your communications with the manufacturer and any receipts or purchase confirmations.
The recall involves the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-0330. The recalled units are distributed worldwide, including 36 in the U.S. The devices were used with Olympus endoscopes and guidewires for papillotomy.
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