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FDA-Device2026-02-25Class IIPROCESSING DEFECT

Wilson-Cook Teslatome Bipolar Sphincterotomes recalled for electrical current hazard

Wilson-Cook
ELECTRICAL SHOCKCACOINNC

Stop using Wilson-Cook Teslatome Sphincterotomes

Wilson-Cook Medical is recalling certain Teslatome Bipolar Sphincterotomes (medical devices used during endoscopic procedures) because some units may contain a manufacturing defect—a void in the material that separates internal channels. This defect can cause electrical current to flow incorrectly during the cutting procedure.

  • If your facility uses Teslatome Sphincterotomes (Model G60784 or G60785), stop using affected units immediately.
  • Check the work order numbers on your devices against the recall list to confirm if you have affected units.
  • Contact Wilson-Cook Medical or your device supplier for instructions on return or replacement.
  • Review patient records for any recent procedures using these devices and follow up as advised by your physician.
Hazard

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.

Sold states
U.S. Distribution to states of: CA, CO, IN, and NC.
Affected count
153
Manufactured in
4900 Bethania Station Rd, Winston Salem, NC, United States
Products
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2026

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