Z-0824-2020Class II

TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877

Name: Z-0824-2020 TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Creator: Acclarent, Inc.
Published: 2019-03-06
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2019-03-06 / Terminated / root cause: design

FDA source

Acclarent, Inc. began a recall of TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 on 2019-03-06. FDA classified it as Class II and gives the reason as "The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0824-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-06
Posted: 2020-01-19
Recalling firm: Acclarent Inc
Product: TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 3/6/19, affected customers were contacted via Phone concerning the recall. On 3/12/19, the firm mailed a "Urgent Medical Device Recall" letter to affected customer via FedEx overnight. In addition to informing the customers about the recall, the letter asked customers to take the following actions: 1. Evaluate your current inventory of Acclarent TruDi Nav Suction Instruments with the identified lot numbers listed above. If you have inventory of the specific lots, DO NOT USE. Remove and return products immediately. 2. To return the products, complete BOTH customer acknowledgment and product return sections of the attached Business Reply Form (BRF)). A local Acclarent sales representative will contact you to retrieve the recalled products. Use the enclosed prepaid shipping label and attach a copy of the completed BRF with your product return. 3. Complete the BRF within three (3) business days of receipt even if you no longer have inventory of the identified products. Upon receipt of the completed BRF and your product return, your account will be credited. Incomplete BRFs cannot be processed. 4. Ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully. 5. Maintain a copy of this communication where the inventory of the lots identified in this letter is located until all products are returned. 6. If you have product complaints or adverse events to report regarding the use of Acclarent products, please inform Acclarent by calling (650) 687-5888 7. For questions related to this issue and product recall, please contact your Acclarent sales representative or call (650) 687-5888
Quantity in commerce: 14 Suction Insstruments
Distribution: US: WI, IL, NE, CA, OH, NY OUS: None
Product codes and lots: Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0824-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0824-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-18
Z-0825-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-18
Z-0826-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-18

Product code PGW

K180948Class IITruDi NAV Suction InstrumentsAcclarent, Inc. / cleared 2018-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)