FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome recalled for potential deformation and performance loss
Stop using Olympus sphincterotome model KD-VC431Q-0730
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC431Q-0730) used in endoscopic procedures. Some devices may not have undergone proper heat treatment during manufacturing, which could cause them to deform and stop working correctly during use.
- Stop using any Olympus sphincterotome model KD-VC431Q-0730 devices immediately
- Contact your Olympus representative or distributor for instructions on device return or replacement
- Check your facility's inventory against the affected material reference numbers: N5391610, N5391630, or N5777930
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
4183 units (821 US, 3362 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-VC431Q-0730; 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-1277-2026More Olympus recalls
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