CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
TruDi Navigation System recalled by Acclarent
Acclarent is recalling TruDi Navigation System, distributed in 30 states. The recall was initiated on 21 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0127-2024
- FDA event ID
- 93087
- Recalling firm
- Acclarent, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Sep 2023
- FDA classified
- 20 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 21 Sep 2023 | Recall initiated by company | |
| 20 Oct 2023 | Classified by FDA | +29 days |
| 1 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Where it was distributed
US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD
AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaHawaiiIowaIdahoIllinoisKansasLouisianaMassachusettsMaineMichiganMinnesotaMissouriNorth CarolinaNebraska
Questions about this recall
Why was it 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.
Which lots are affected?
TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)
Where was it sold?
US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Acclarent
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TruDi NAV Suction Instruments: 0-Degree recalled by Acclarent | Acclarent | Packaging Defects | 39 states |
| Device | CLASS II | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle recalled by Acclarent | Acclarent | Other | 6 states |
| Device | CLASS II | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle recalled by Acclarent | Acclarent | Other | 6 states |
| Device | CLASS II | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle recalled by Acclarent | Acclarent | Other | 6 states |
| Device | CLASS III | Relieva Flex Sinus Guide Catheter F recalled by Acclarent | Acclarent | Other | TX |
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