Olympus Corporation of the Americas recalled 5,089 sphincterotomes on January 7, 2026, due to potential deformation. The devices may lose performance if they did not undergo thermoforming. Healthcare providers and patients should cease use 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 Single Use 3-Lumen Sphincterotome V is a medical instrument designed for use with an Olympus endoscope and guidewire for papillotomy procedures. Healthcare providers use it to perform specific gastrointestinal interventions, relying on its precise functionality.
If the sphincterotome does not undergo proper thermoforming, it may deform, affecting its ability to function as intended during medical procedures. This could lead to ineffective treatment or complications.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face potential risks during procedures if the device is used. Immediate action is necessary to ensure safety and compliance with the recall.
The model number can typically be found on the device packaging or in the user manual.
Expect a refund or instructions for replacement within 4-6 weeks after contacting Olympus.
Keep all receipts, correspondence, and any records of complaints regarding the device for your records.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0330. These devices were distributed worldwide, including 30 units in the US and 5,059 internationally. No price was mentioned.
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