FDA Device recall Z-0415-2022
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z
- FDA Device
- Class II
- ongoing
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z by Acclarent, citing 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 su….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0415-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-12 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acclarent |
| Distribution | AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WI, WV, WY |
Product
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Reason
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.
Identifiers
| code_info | 0-Degree Lots: 1903120, 1903250, 1904060, 1904180, 1904240, 1905030, 1905070, 1906260, 1907120, 1907170, 1907220, 19072…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Acclarent
- TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
FDA Device · Class II · 2023-11-01 · Acclarent - TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
FDA Device · Class II · 2020-01-29 · Acclarent - TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
FDA Device · Class II · 2020-01-29 · Acclarent - TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
FDA Device · Class II · 2020-01-29 · Acclarent - RELIEVA FLEX Sinus Guide Catheter F-70
FDA Device · Class III · 2015-06-17 · Acclarent
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0415-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.