Olympus Corporation of the Americas recalled 10,008 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. Healthcare providers and patients must stop using them 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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Model/Catalog Number: KD-VC411Q-0720. Distributed worldwide, including 3,038 units in the US and 6,970 units internationally. No price information available.
The sphincterotome may deform and lose performance if it did not undergo proper thermoforming. This poses a significant risk during medical procedures, potentially leading to complications.
No specific incidents reported. However, the potential for device deformation raises concerns regarding patient safety.
Stop using the device immediately. Follow recall instructions from Olympus Corporation or your healthcare provider.
Contact Olympus Corporation of the Americas for further instructions. Visit their website or call for assistance.
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