FDA Medical Device Recalls (openFDA)
Acclarent, Inc.: TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
- Recall number
- Z-0127-2024
- Recalling firm
- Acclarent, Inc.
- Product
- TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
- Status
- Open, Classified
- Initiated
- 2023-09-21
- Posted
- 2023-10-20
- Terminated
- not on file
- Reason
- 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
- 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 OneMD-Field-Actions@its.jnj.com 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
- 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
- Lot, serial or model codes
- TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)
- 510(k) numbers
- ["K192397"]
- PMA numbers
- not on file
- Product code
- PGW
- Firm FEI
- 3005172759
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28