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-VC433Q-0720
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC433Q-0720) used in endoscopic procedures. Some devices may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working correctly during a procedure.
- Stop using any Olympus sphincterotome model KD-VC433Q-0720 in your facility immediately
- Check your inventory for affected devices using the model number KD-VC433Q-0720 and material reference numbers N5391710, N5391730, or N5778030
- Contact Olympus or your medical device supplier for instructions on how to return or dispose of recalled devices
- Contact Olympus if you have already used these devices on patients to discuss any follow-up actions
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
1504 units (350 US, 1154 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-VC433Q-0720; 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-1283-2026More Olympus Corporation of the Americas recalls
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- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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