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
Recall Summary CleverCut Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0320) are being recalled because some units may not have been properly formed during manufacturing, which could cause them to deform and not work as intended. These are surgical instruments used with Olympus endoscopes during certain digestive tract procedures. The recall affects devices distributed by Olympus Corporation of the Americas.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- 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.
- Reason
- Devices which did not undergo thermoforming could deform and lose performance.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/017c0c6e-9f97-4674-b1ae-762bcd129cde