Acclarent, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005Class IISep 21, 2023When using affected curette and software, there is a discrep	When using affected curette and software, there is a discrepancy between the actual curette tip location and t	Class IIDevices	Sep 21, 2023
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090ZClass IINov 12, 2021Suction Instruments were incorrectly calibrated so they may	Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for vis	Class IIDevices	Nov 12, 2021