Olympus Corporation of the Americas recalled 7,046 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using these devices 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 in endoscopic procedures to facilitate papillotomy. Healthcare professionals purchase it for its ability to precisely navigate and perform procedures involving the bile ducts.
The devices in question did not undergo proper thermoforming, which can cause them to lose shape and functionality during medical procedures. This deformation can lead to serious complications if not identified prior to use.
This recall is not part of a broader industry pattern.
Patients may face delays in medical procedures requiring this device, and healthcare providers must find alternative methods, impacting patient care and operational efficiency.
The model number can typically be found on the device packaging or the device itself, usually near the manufacturer's label.
Expect refund processing to take 4-6 weeks once the return request is initiated.
Keep receipts, correspondence with the manufacturer, and photographs of the recalled device for your records.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1530. It was designed for use with an Olympus endoscope and guidewire for papillotomy. The devices were distributed widely across the U.S. and internationally.
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