Z-0127-2024Class II

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

Name: Z-0127-2024 TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z...
Creator: Acclarent, Inc.
Published: 2023-09-21
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2023-09-21 / Open, Classified / root cause: software

FDA source

Acclarent, Inc. began a recall of TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 on 2023-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0127-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-21
Posted: 2023-10-20
Recalling firm: Acclarent Inc
Product: TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 9/21/23, correction notices were mailed to customers who were asked to do the following: Please cease using the affected curette device with the affected navigation system until the new version of navigation system software version 2.3.2 is installed. 2. Please do not return any of the curettes within your inventory. 3. Complete and return the business response form via email to [email protected] 4. Forward this notice to any personnel in your facility that needs to be informed. 5. If any of the affected products have been forwarded to another facility, contact that facility and provide a copy of this to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness If any adverse reactions or quality problems are experienced during the use of the affected navigation system with the curette, please report any issues to the firm via the product complaint phone number:1-877-775-2789, Option # 5.
Quantity in commerce: 141
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
Product codes and lots: TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0127-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0127-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-20

Product code PGW

K192397Class IITruDi Navigation SystemBiosense Webster / cleared 2020-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)