FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential deformation
Check Olympus sphincterotome model KD-VC412Q-0215
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC412Q-0215) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working correctly during use.
- If you have this device in stock, check the model number KD-VC412Q-0215 and material reference numbers (N5391410, N5391430, or N5777730)
- Contact Olympus Corporation or your distributor for instructions on return or replacement
- Do not use affected devices in patient procedures
Hazard
Devices which did not undergo thermoforming could deform and lose performance.
Who it affects
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
Affected count
1918 units (413 US, 1505 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2026More Olympus recalls
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