Company: Acclarent, Inc. Date of Enforcement Report: 10/20/2023 Class II PRODUCT TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Recall Number: Z-0127-2024 REASON: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended...Read More

Wavi Co. was issued a warning letter from the FDA for reason of “failure to perform validation of device software as required by 21 CFR 820.30(g).” More specifically, “Your firm distributed at least 90 WAVi Complete Systems consisting of WAVi Headsets, WAVi eSoc single use electrodes, electrode contacts, Electronic Processing Units [EPU], ear clips, Heart...Read More