Use caution Medical device recall · FDA · Published September 21, 2023

Acclarent TruDi Navigation System Recall: Discrepancy May Cause Surgery Delays or Injury

Acclarent recalls TruDi Navigation System (FG-2000-00) used with specific curettes due to location mismatch during ENT surgery, risking prolonged procedures, CSF leaks, or structural damage. Affected units sold with certain software versions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0127-2024Medical device Acclarent ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAcclarent, Inc.31 Technology Dr Suite 200 · Irvine, CA 92618-2346

✎ GovInfoNow plain-language explainer

Acclarent is recalling its TruDi Navigation System when used with specific curettes because the system may show incorrect tip locations during ear, nose, and throat surgery. This could lead to longer surgeries, cerebrospinal fluid leaks, vision problems, or damage to skull structures. Read more at govinfonow.com/recall/57289-acclarent-trudi-navigation-system-recall-discrepancy-may-cause-surgery-delays.

Source Summary by GovInfoNow · govinfonow.com/recall/57289-acclarent-trudi-navigation-system-recall-discrepancy-may-cause-surgery-delays · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0127-2024

Cite this page

“Acclarent TruDi Navigation System Recall: Discrepancy May Cause Surgery Delays or Injury.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57289-acclarent-trudi-navigation-system-recall-discrepancy-may-cause-surgery-delays. Based on FDA recall #Z-0127-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0127-2024%22&limit=1).

The FDA announced on September 21, 2023, that Acclarent, Inc. is recalling the TruDi Navigation System, Model FG-2000-00, Catalog ENS022B, when used with specific TruDi Curette models due to a location discrepancy hazard. This recall affects 141 units distributed across multiple U.S. states.

How to tell if you have it

Brand: Acclarent
Product: TruDi Navigation System, Model FG-2000-00, Catalog ENS022B
Compatible Curette Models: TDC0005Z and TDC0005
Software Version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)
UDI-DI: 10846835018639
Quantity: 141 units

The hazard

According to the FDA, a discrepancy exists between the actual curette tip location and the location displayed on the navigation system during ENT and skull base surgery. This error may cause delayed or prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

Context

GovInfoNow's records show Acclarent, Inc. has two other recalls on record since March 6, 2019. On November 12, 2021, the company recalled TruDi NAV Suction Instruments due to calibration errors that risked tissue damage. Other recent recalls of similar products include the Encore Medical EMPOWR Acetabular System Recall (January 5, 2026) and the GE Medical Systems Imactis CT-Navigation System Recall (February 3, 2026).

How to tell if you have this one

Check for TruDi Navigation System model FG-2000-00 with catalog ENS022B. Affected curettes are models TDC0005Z and TDC0005. The software version may be V2.3.1 Update (2.3.1.144 or 2.3.1.166).

Brand
Acclarent
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify if your TruDi Navigation System is model FG-2000-00 with catalog ENS022B and if it's used with curettes TDC0005Z or TDC0005.

Where it went and when

Where it was distributed

Distributed in 29 states and D.C..

FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Wisconsin.

Recall timeline

FDA published this recall 41 days after the firm started it.

Sep 21, 2023Firm started the recall
Oct 20, 2023FDA classified it Class II
Nov 1, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Acclarent recalls

Link to this recall

<a href="https://govinfonow.com/recall/57289-acclarent-trudi-navigation-system-recall-discrepancy-may-cause-surgery-delays">Acclarent TruDi Navigation System Recall: Discrepancy May Cause Surgery Delays or Injury (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0127-2024 (September 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0127-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.