Olympus Corporation of the Americas recalled 3,954 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall occurred due to devices that may not have undergone proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients should stop using the devices immediately and follow the recall instructions.
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 instrument designed for use in papillotomy procedures. Healthcare providers purchase it for its ability to facilitate specific endoscopic interventions.
Improper thermoforming can cause the device to deform during use, potentially compromising its effectiveness in medical procedures. This can pose serious risks to patient safety.
This recall is not part of a broader industry pattern.
Consumers must stop using the affected devices immediately, which could lead to delays in scheduled procedures and a need for alternative instruments.
The model number is typically located on the packaging or the device itself. Check any accompanying documentation as well.
Expect a refund or replacement processing time of 4-6 weeks.
Keep records of all correspondence regarding the recall, including emails and phone call notes. Document any usage of the device prior to recall notification.
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1520. It was distributed worldwide, including across all U.S. states. The product is used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
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