Product Name: Single Use 3-lumen Sphincterotome V (distal Wire Guided) Model/catalog Number: Kd-vc411q-0720; Software Version: N/a Product Description: These Instruments Have Been Designed To Be Used
Recall Summary Olympus is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0720), which are surgical instruments used during endoscopic procedures to cut the pancreatic duct opening. Some devices may not have been properly heat-formed during manufacturing, which could cause them to deform and not work as intended. This recall affects the specific model and lot numbers distributed by Olympus Corporation of the Americas.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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.
- 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/36901125-a2b1-4a90-9e07-5dbb5ba5b229