Acclarent Recalls
13 recalls on record · August 7, 2013 to November 1, 2023 · Medical Devices
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 1, 2023Medical DevicesFDA
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Hazard: 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.
December 29, 2021Medical DevicesFDA
Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Hazard: 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.
January 29, 2020Medical DevicesFDA
Acclarent, Inc. recalls TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Hazard: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
January 29, 2020Medical DevicesFDA
Acclarent, Inc. recalls TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Hazard: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
January 29, 2020Medical DevicesFDA
Acclarent, Inc. recalls TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Hazard: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
June 17, 2015Medical DevicesFDA
Acclarent, Inc. recalls RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide
Hazard: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Hazard: 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.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Hazard: 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.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Hazard: 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.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Hazard: 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.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Hazard: 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.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Hazard: 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.
August 7, 2013Medical DevicesFDA
Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Hazard: 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.