Olympus Corporation of the Americas: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Olympus Corporation of the Americas
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; 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.
- Reason / hazard
- Devices which did not undergo thermoforming could deform and lose performance.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-01-07
- Code info
- Model/Catalog Number: KD-V411M-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; All Lots with a valid expiration date
- Product quantity
- 136037 units (9959 US, 126078 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 98252
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