Acclarent recalls
Acclarent appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2023-11-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2013-08-07 to 2023-11-01 |
| By agency | FDA Device (13) |
| By classification | Class II (12), Class III (1) |
| By status | terminated (11), ongoing (2) |
| Distribution named in notices | AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, US, UT, VA, WI, WV, WY |
Recalls
- 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
Reason: 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 T… - TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z
FDA Device · Class II · 2021-12-29 · Acclarent
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… - TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
FDA Device · Class II · 2020-01-29 · Acclarent
Reason: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. - TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
FDA Device · Class II · 2020-01-29 · Acclarent
Reason: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. - TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
FDA Device · Class II · 2020-01-29 · Acclarent
Reason: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. - RELIEVA FLEX Sinus Guide Catheter F-70
FDA Device · Class III · 2015-06-17 · Acclarent
Reason: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent
Reason: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.