TruDi Navigation System, Model: FG-2000-00, Catalog:… recallZ-0127-2024 · Acclarent, Inc. · initiated Sep 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Acclarent, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-0127-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 21, 2023
- Posted by the FDA
- Oct 20, 2023
- Recalling firm
- Acclarent, Inc.
- Quantity
- 141
- Product code
- PGW
- FDA submissions
- K192397
- 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 description
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Code information (models, lots, serial numbers)
TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TruDi™ Navigation System 1Biosense Webster (Israel) Ltd. · Ear, Nose, and Throat Stereotaxic Instrument1 recall14 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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