CLASS II Device recall · Reported 29 Jan 2020 · FDA Enforcement Report

TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle recalled by Acclarent

Acclarent is recalling TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, 10705031245891, distributed in California, Illinois, Nebraska, New York, Ohio, Wisconsin. The recall was initiated on 6 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0826-2020
FDA event ID: 84398
Recalling firm: Acclarent, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Mar 2019
FDA classified: 18 Jan 2020
Reported: 29 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Mar 2019	Recall initiated by company
18 Jan 2020	Classified by FDA	+318 days
29 Jan 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

Product as listed by the FDA

TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891

Where it was distributed

US: WI, IL, NE, CA, OH, NY OUS: None

California Illinois Nebraska New York Ohio Wisconsin

Questions about this recall

Why was it recalled?

The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

Which lots are affected?

Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

Where was it sold?

US: WI, IL, NE, CA, OH, NY OUS: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 84398

This product is part of a recall event; the main page for the event is TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle recalled by Acclarent.

Reported	Class	Recall	Company	Reason	Where
29 Jan 2020	CLASS II	TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states
29 Jan 2020	CLASS II	TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states

More recalls from Acclarent

All 13

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023Device	CLASS II	TruDi Navigation System recalled by Acclarent	Acclarent	Packaging Defects	30 states
29 Dec 2021Device	CLASS II	TruDi NAV Suction Instruments: 0-Degree recalled by Acclarent	Acclarent	Lead & Heavy Metals	39 states
29 Jan 2020Device	CLASS II	TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states
29 Jan 2020Device	CLASS II	TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states
17 Jun 2015Device	CLASS III	Relieva Flex Sinus Guide Catheter F recalled by Acclarent	Acclarent	Other	TX

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