FDASeptember 21, 2023device
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
acclarent
UPCs
10846835018639
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z2021-11-12
- FDATruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 107050312458842019-03-06
- FDATruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 107050312458912019-03-06
- FDATruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)107050312458772019-03-06
- FDARELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .2015-04-28
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →