FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential deformation and performance loss
OTHERNationwide distribution
Check Olympus sphincterotome devices for deformation
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working properly during use.
- Contact Olympus Corporation if your facility has these devices (Model KD-VC411Q-0320)
- Do not use affected devices until you confirm the lot number with Olympus
- Check the UDI-DI numbers: 04953170466403 to identify potentially affected stock
- Follow Olympus instructions for device inspection or replacement
Hazard
Devices which did not undergo thermoforming could deform and lose performance.
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
5946 units (2208 US, 3738 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-VC411Q-0320; 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-1280-2026More Olympus Corporation of the Americas recalls
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