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 KD-V411M-3025 sphincterotome
Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (Model KD-V411M-3025) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing and could deform or stop working correctly during use.
- Stop using affected devices immediately
- Check your inventory for Model KD-V411M-3025 with Material REF N1090210
- Contact your Olympus representative or the FDA for guidance on returning or replacing affected units
- Verify that replacement devices have undergone proper thermoforming before use
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
1025 units (OUS only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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-1296-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
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- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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