CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
TruDi NAV Suction Instruments: 0-Degree recalled by Acclarent
Acclarent is recalling TruDi NAV Suction Instruments: 0-Degree, distributed in 39 states. The recall was initiated on 12 Nov 2021 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-0415-2022
- FDA event ID
- 89170
- Recalling firm
- Acclarent, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2021
- FDA classified
- 22 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 12 Nov 2021 | Recall initiated by company | |
| 22 Dec 2021 | Classified by FDA | +40 days |
| 29 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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 NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Where it was distributed
US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID
AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
0-Degree Lots: 1903120, 1903250, 1904060, 1904180, 1904240, 1905030, 1905070, 1906260, 1907120, 1907170, 1907220, 1907240, 1907260, 2003040, 2009110, 2011240, 2102080, 2103090, 2104260, 2105040, 2105260, 2106100, 2107070. 70-Degree Lots: 1903137, 1903257, 1904067, 1905017, 1905037, 1905077, 1906067, 1906267, 1907127, 1908137, 1908157, 2003127. 90-Degree: 1903139, 1903259, 1904069, 1905019, 1905139, 1906079, 1908269, 1909279, 1909309, 1910299, 2003029, 2004029
Where was it sold?
US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID
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 Navigation System recalled by Acclarent | Acclarent | Packaging Defects | 30 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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