Irvine, CA, United States
Acclarent, Inc. recalls
3 recalls recorded since 2018, most recently on 21 September 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 September 2023
- 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 Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0127-2024
- TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Ongoing Class II Medical devices
- Recall started
- 12 November 2021
- 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.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0415-2022
- TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Terminated Class II Medical devices
- Recall started
- 6 March 2019
- 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.
- Distribution
- US: WI, IL, NE, CA, OH, NY OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0825-2020, Z-0826-2020, Z-0824-2020
- TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
- TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
- TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.