Olympus Corporation recalled 887 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform and lose performance if not properly thermoformed. The recall affects both US and international markets.
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 instrument used with an Olympus endoscope for papillotomy procedures. This device allows for the precise cutting of tissue using high-frequency current, making it crucial for various gastrointestinal interventions.
The risk arises when the devices do not undergo proper thermoforming, resulting in potential deformation. This deformation can compromise the device's performance during critical medical procedures.
This recall is not part of a broader industry pattern.
The recall presents a significant risk to patient safety, requiring immediate cessation of use and potential medical procedure delays for those affected.
The model number and expiration date can typically be found on the device packaging or the device label itself.
Expect a refund or replacement process to take approximately 4-6 weeks.
Document any communications with the manufacturer, including emails and phone call notes. Keep the product and packaging as evidence.
The recalled product is the Disposable Triple Lumen Sphincterotome, Model Number KD-411Q-0730. It was distributed worldwide, with 650 units sold in the United States and 237 units internationally.
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