Reported Nov 1, 2023 · Ongoing
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Acclarent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acclarent, Inc. · 31 Technology Dr Suite 200 · Irvine, CA · 92618-2346
Is this the product you have?
- TruDi Navigation System
- ModelFG-2000-00
- CatalogENS022B, when used with TruDi Curette
- ModelsTDC0005Z and TDC0005
- Lot codes and dates
- TruDi Navigation System
- UDI-DI10846835018639
- software versionV2.3.1 Update (2.3.1.144 and 2.3.1.166)
- Amount recalled
- 141
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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