FDANovember 12, 2021device
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
What to do
FDA enforcement status: Ongoing
Brands named
acclarent
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC00052023-09-21
- 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
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