FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus CleverCut Single Use 3-Lumen Sphincterotome recalled for potential deformation
Stop using Olympus CleverCut sphincterotome devices
Olympus has recalled certain CleverCut Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0320) used in endoscopy procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and lose effectiveness during use. No injuries have been reported.
- Stop using affected CleverCut sphincterotome devices immediately
- Check your inventory for model KD-V411M-0320 with material references N1089430, N1089410, or N5411130
- Contact Olympus or your supplier for instructions on device return or replacement
- Verify any affected devices have not been used on patients
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
72023 units (3920 US, 68103 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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-1268-2026More Olympus recalls
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