Acclarent, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0127-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

Product Classification:

Class II

Date Initiated: September 21, 2023

Date Posted: November 1, 2023

Recall Number: Z-0127-2024

Event ID: 93087

Reason for Recall:

When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

Status: Ongoing

Product Quantity: 141

Code Information:

TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)

Distribution Pattern:

US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD

Voluntary or Mandated:

Voluntary: Firm initiated