Acclarent, Inc.
United StatesFDA applicant, unverified FDA FEI 3005172759
Acclarent, Inc. is a medical device manufacturer, with 173 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 15 FDA recalls as of 12 Nov 2026.
- Devices
- 173
- Registrations
- FDA
- FDA recalls
- 152 ongoing
Registry facts
- Registries
- FDA GUDID 128
- FDA 510(k) 45
- Device classes
- FDA Class I 100
- FDA Class II 73
- FDA recalls
- Identifiers
- FDA FEI 3005172759
- DUNS 361092450
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Acclarent, Inc. makes
ACCLARENT, INC. manufactures medical devices for ear, nose, and throat (ENT) procedures, including nasal haemostatic balloons, nasal/paranasal balloon catheters, bronchial balloon catheters, metal/carbide ENT burrs, Eustachian catheters, paranasal sinus guide-catheters, paranasal sinus-illumination light guide cables, and electromagnetic/optical surgical navigation device tracking systems.
The company's portfolio includes Class I and Class II devices, which are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
Search and filter all 173 devicesShowing 1-50 of 173
Company details
- FDA FEI number
- 3005172759
- DUNS number
- 361092450
- Address
- 7585 Irvine Center Dr, Irvine, CA, 92618
- Phone
- +1(800)654-2873
FDA recalls
FDA recall records list 15 recalls initiated by ACCLARENT, INC., the earliest on 2006-01-20 and the most recent on 2023-09-21. By recorded status: 2 ongoing and 13 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 3
- 2020 0
- 2021 1
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 21 Sep 2023 Z-0127-2024 Class II Ongoing 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.
Full distribution text
- 21 Sep 2023 Z-0127-2024 Class II Ongoing 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.
2021
- 12 Nov 2021 Z-0415-2022 Class II Ongoing 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.
Full distribution text
- 12 Nov 2021 Z-0415-2022 Class II Ongoing 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.
2019
- 6 Mar 2019 Z-0824-2020 Class II Terminated The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- 6 Mar 2019 Z-0825-2020 Class II Terminated The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- 6 Mar 2019 Z-0826-2020 Class II Terminated The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
2015
- 28 Apr 2015 Z-1740-2015 Class III Terminated Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
2013
- 11 Jan 2013 Z-1860-2013 Class II Terminated 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.
- 11 Jan 2013 Z-1861-2013 Class II Terminated 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.
- 11 Jan 2013 Z-1862-2013 Class II Terminated 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.
- 11 Jan 2013 Z-1863-2013 Class II Terminated 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.
Show all 15 recalls
2013
- 11 Jan 2013 Z-1864-2013 Class II Terminated 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.
- 11 Jan 2013 Z-1865-2013 Class II Terminated 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.
- 11 Jan 2013 Z-1866-2013 Class II Terminated 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.
2012
- 30 Jan 2012 Z-1095-2012 Not yet classified Terminated Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
Full distribution text
- 30 Jan 2012 Z-1095-2012 Not yet classified Terminated Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
2006
- 20 Jan 2006 Z-0559-06 Unclassified (pre-2012) Terminated Device sterility may be compromised as evidenced by a loss of package integrity.
Full distribution text
- 20 Jan 2006 Z-0559-06 Unclassified (pre-2012) Terminated Device sterility may be compromised as evidenced by a loss of package integrity.
Frequently asked questions
How many devices does ACCLARENT, INC. have in the registry?
The registry currently lists 173 devices for ACCLARENT, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ACCLARENT, INC.'s devices?
Among its 50 most recently registered devices, ACCLARENT, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do ACCLARENT, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ACCLARENT, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ACCLARENT, INC.?
FDA recall records list 15 recalls initiated by ACCLARENT, INC., the most recent initiated on 21 Sep 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ACCLARENT, INC. in the registry?
The most recently registered devices listed for ACCLARENT, INC. include TruDi® TDNC001, RELIEVA FLEX GC000RF, TruDi Curette TDC0005Z and RELIEVA LUMA SISLGCAWOLF.