Wilson-Cook Medical recalled 153 units of its Bipolar Sphincterotomes on December 18, 2025. A void in the device's material may cause an inappropriate electrical current during use. The recall affects specific models distributed in California, Colorado, Indiana, and North Carolina.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Wilson-Cook Medical Inc. or your healthcare provider for instructions. Notification method: Letter
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Bipolar Sphincterotomes are medical devices used during endoscopic procedures for cannulation of the biliary ducts. They are crucial for performing sphincterotomies, which help in the treatment of various biliary conditions.
The defect may create a void between the wire guide and cutting wire lumens, causing an improper electrical current path during use. This could lead to unintended cuts or burns during the procedure.
This recall is not part of a broader industry pattern.
The recall necessitates immediate cessation of use, creating potential delays in medical treatments for affected patients.
The REF number and model number can typically be found on the product packaging or on the device itself near the handle or control panel.
Expect a timeline of 4-6 weeks for processing refunds after the manufacturer receives the returned devices.
Keep records of your purchase, any correspondence regarding the recall, and photos of the device for your records.
The recalled products include Teslatome Bipolar Sphincterotomes with REF numbers TESLA-B2535-260 (Model G60784) and TESLA-B2535-450 (Model G60785). Each unit has a UDI-DI code, 00827002607842 and 00827002607859 respectively. The devices were distributed in California, Colorado, Indiana, and North Carolina.
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