FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential deformation and performance loss
OTHERNationwide distribution
Stop using Olympus sphincterotome model KD-VC411Q-0330
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0330) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and not work as intended during use.
- Check your facility's inventory for model KD-VC411Q-0330 with any valid expiration date
- Stop using affected devices immediately
- Contact Olympus or your distributor for instructions on device replacement or return
- Review any procedures performed with these devices and consult clinical judgment if needed
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
5089 units (30 US, 5059 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-0330; 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-1281-2026More Olympus Corporation of the Americas recalls
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