Z-0415-2022Class II

TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

Name: Z-0415-2022 TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Creator: Acclarent, Inc.
Published: 2021-11-12
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2021-11-12 / Open, Classified / root cause: manufacturing process

FDA source

Acclarent, Inc. began a recall of TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z on 2021-11-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0415-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-12
Posted: 2021-12-22
Recalling firm: Acclarent Inc
Product: TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/12/21, recall notices were sent to OR Directors, Risk Managers, or Material Managers. Customers were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3) If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4) Complete the Business Reply Form and return to [email protected] 5) After the Business reply Form is received a return kit will be sent. 6) Keep this notice visibly posted for awareness until all product subject to this recall has been returned. Customers with additional questions are encouraged to call the recalling firm at 1-877-775-2789, 4:00am-5:00pm PST.
Quantity in commerce: 1543
Distribution: US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID
Product codes and lots: 0-Degree Lots: 1903120, 1903250, 1904060, 1904180, 1904240, 1905030, 1905070, 1906260, 1907120, 1907170, 1907220, 1907240, 1907260, 2003040, 2009110, 2011240, 2102080, 2103090, 2104260, 2105040, 2105260, 2106100, 2107070. 70-Degree Lots: 1903137, 1903257, 1904067, 1905017, 1905037, 1905077, 1906067, 1906267, 1907127, 1908137, 1908157, 2003127. 90-Degree: 1903139, 1903259, 1904069, 1905019, 1905139, 1906079, 1908269, 1909279, 1909309, 1910299, 2003029, 2004029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0415-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0415-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-22

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)