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All Recalls

Every Acclarent, Inc. Recall

Sorted by most recent. Click any recall for full details.

9 recalls
High RiskFDA
Acclarent, Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Medical Devices·141 affected·Sep 21, 2023
High RiskFDA
Acclarent, Inc.
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Medical Devices·0 affected·Mar 6, 2019
High RiskFDA
Acclarent, Inc.
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Medical Devices·0 affected·Mar 6, 2019
RecallFDA
Acclarent, Inc.
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to acces...
Surgical Devices·986 affected·Apr 28, 2015
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Medical Devices·1,920 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·2,703 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·625 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·1,217 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·3,324 affected·Jan 11, 2013