Olympus Corporation of the Americas recalled 12,641 Single Use Sphincterotome V devices on January 7, 2026. The devices may deform due to a manufacturing defect, posing a high risk of performance failure. Healthcare providers and patients must stop using these instruments 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 Sphincterotome V is a medical instrument designed for use during endoscopic procedures to facilitate papillotomy. Healthcare providers utilize this device to aid in the treatment of various gastrointestinal conditions.
Improper thermoforming during manufacturing can cause these devices to deform, compromising their functionality and safety during procedures. This issue can lead to significant risks in patient care.
This recall is not part of a broader industry pattern.
Patients relying on this device for medical procedures face potential safety risks. Healthcare providers must act quickly to halt usage and ensure patient safety.
The model number is typically found on the device packaging or printed on the device itself.
Expect a 4-6 week timeline for processing refunds or replacements following the recall instructions.
Keep records of your purchase, any communications with Olympus, and photos of the device if required for the recall process.
The affected model is the Single Use Sphincterotome V, Model/Catalog Number: KD-VC431Q-0720. These devices were distributed worldwide, including 8,789 units in the U.S. They are designed for use with Olympus endoscopes and guidewires for papillotomy, using high-frequency current.
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