Use caution Medical device recall · FDA · Published November 12, 2021

Acclarent TruDi NAV Suction Instruments Recall: Calibration Error Risks Tissue Damage

Acclarent recalls TruDi NAV Suction Instruments (0°, 70°, 90° models) due to calibration errors that may cause tissue damage or carotid artery injury during surgery. Affected units include specific lot numbers from 2019-2021.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0415-2022Medical device Acclarent ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAcclarent, Inc.31 Technology Dr Suite 200 · Irvine, CA 92618-2346

✎ GovInfoNow plain-language explainer

Acclarent is recalling TruDi NAV Suction Instruments that may not be calibrated correctly, risking tissue damage or injury to critical structures during surgery. This affects specific model numbers and production lots. Read more at govinfonow.com/recall/61542-acclarent-trudi-nav-suction-instruments-recall-calibration-error-risks-tissue.

Source Summary by GovInfoNow · govinfonow.com/recall/61542-acclarent-trudi-nav-suction-instruments-recall-calibration-error-risks-tissue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0415-2022

Cite this page

“Acclarent TruDi NAV Suction Instruments Recall: Calibration Error Risks Tissue Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61542-acclarent-trudi-nav-suction-instruments-recall-calibration-error-risks-tissue. Based on FDA recall #Z-0415-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0415-2022%22&limit=1).

The FDA announced on November 12, 2021, that Acclarent, Inc. is recalling TruDi NAV Suction Instruments due to calibration errors that may cause inaccurate device location during surgery. The agency stated the recall is voluntary and initiated by the firm.

How to tell if you have it

Brand: Acclarent
Product: TruDi NAV Suction Instruments (0-Degree REF: TDNS000Z, 70-Degree REF: TDNS070Z, 90-Degree REF: TDNS090Z)
Units affected: 1543
Distribution: US states including 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, MD, ID

The hazard

The suction instruments were incorrectly calibrated and may not meet system accuracy specifications for visual verification of device location in patient anatomy. If the surgeon does not detect this error, it could lead to intraprocedural delay, reversible tissue damage, damage to the carotid artery, CSF leak, or damage to the optic nerve.

Context

GovInfoNow's records show Acclarent, Inc. has two other recalls on record since March 6, 2019. On September 21, 2023, the company issued a recall for the TruDi Navigation System due to discrepancies between actual curette tip location and displayed locations. On March 6, 2019, Acclarent recalled NAV Suction Instruments because calibration issues caused incorrect tip orientation display in the system. Other recent recalls of similar products include Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (November 6, 2025), Boston Scientific OverStitch Suture Cinch Recall (July 14, 2026), and da Vinci S/Si Cautery Hook Recall (December 9, 2025).

How to tell if you have this one

Check for the model name (0-Degree, 70-Degree, or 90-Degree) and the reference code (TDNS000Z, TDNS070Z, or TDNS090Z). Affected units include specific production lots listed in the recall notice.

Brand
Acclarent
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Instrument Model
Identify the model (0-Degree, 70-Degree, or 90-Degree) and reference code (TDNS000Z, TDNS070Z, or TDNS090Z) on the instrument.
Verify Lot Number
Compare the lot numbers listed in the recall notice to determine if your instrument is affected.

Where it went and when

Where it was distributed

Distributed in 39 states.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 47 days after the firm started it.

Nov 12, 2021Firm started the recall
Dec 22, 2021FDA classified it Class II
Dec 29, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61542-acclarent-trudi-nav-suction-instruments-recall-calibration-error-risks-tissue">Acclarent TruDi NAV Suction Instruments Recall: Calibration Error Risks Tissue Damage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0415-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0415-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.