CleverCut recalled 72,023 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. 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 3-Lumen Sphincterotome V is a medical device designed for use with an Olympus endoscope for papillotomy procedures. These instruments are critical for specific surgical procedures that require precise performance.
Devices that did not undergo proper thermoforming can deform, leading to a loss of performance during medical use. This defect can endanger patient safety during procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to ensure safety. The potential for device failure poses significant risks during medical procedures.
The model number and expiration date can typically be found on the packaging or accompanying documentation of the device.
Expect a refund or replacement processing time of approximately 4 to 6 weeks.
Keep all relevant documentation, including purchase receipts, correspondence with the manufacturer, and records of any medical procedures involving the device.
The recalled product is the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320. It was distributed to healthcare facilities globally, including across 39 U.S. states. The total quantity recalled is 72,023 units.
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