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.
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.
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.
The navigation system shows a different curette tip position than the actual location during surgery. This mismatch can cause the procedure to take longer, increase the risk of cerebrospinal fluid leaks, vision damage, or structural harm to the skull.
Surgical teams using the TruDi Navigation System with the affected curettes for ENT procedures are at risk. Patients undergoing skull base surgery with these devices may face complications.
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).
Identify if your TruDi Navigation System is model FG-2000-00 with catalog ENS022B and if it's used with curettes TDC0005Z or TDC0005.
The navigation system may show incorrect curette tip locations during ENT surgery, which could lead to longer procedures, cerebrospinal fluid leaks, vision issues, or skull damage.
Check if your TruDi Navigation System is model FG-2000-00 with catalog ENS022B and if it's used with curettes TDC0005Z or TDC0005. If affected, contact Acclarent for guidance.
The recall record does not specify a remedy or fix; affected users should contact Acclarent directly for instructions.
We’ve drafted a message you can send Acclarent to request your refund or repair — edit it as you like.
Subject: Recall Z-0127-2024 — Acclarent Acclarent Hello, I own a Acclarent that is covered by recall Z-0127-2024 from Acclarent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
