Olympus Corporation of the Americas device recall (Cls II)

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. — Status: Ongoing