TruDi Navigation System position discrepancy during ENT surgery
A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical navigation system with a positioning error that could result in serious surgical complications including cerebrospinal fluid leaks, vision loss, and skull base damage. No illnesses or injuries have been reported; the hazard is potential rather than confirmed, which caps the score at 3 per the rubric.
Plain-English summary
Acclarent, Inc. is recalling the TruDi Navigation System (Model FG-2000-00, Catalog ENS022B) when used with TruDi Curette models TDC0005Z and TDC0005. The affected software version is V2.3.1 Update (2.3.1.144 and 2.3.1.166). The recall involves 141 units distributed across 30 US states.
The TruDi Navigation System is used during ear, nose, and throat (ENT) and skull base surgical procedures to help surgeons visualize and track the location of the curette tip. The recalled units contain a discrepancy between the actual location of the curette tip and the location displayed on the navigation system.
This positioning discrepancy may result in delayed or prolonged surgical procedures, cerebrospinal fluid leaks, visual impairment, or damage to skull base structures. These complications can occur during surgical procedures when the surgeon relies on the incorrect position information displayed by the system.
The recalled product
- Product
- TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
- Manufacturer
- Acclarent, Inc.
- Affected units
- 141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- TruDi Navigation System
- UDI-DI: 10846835018639
- software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)
Distribution
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