# FDA recall Z-0415-2022

> **Acclarent, Inc.** · Class II · device recall initiated 2021-11-12.

## Product

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

## 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.

## 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

## Key facts

- **Recall number:** Z-0415-2022
- **Recalling firm:** Acclarent, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-12
- **Report date:** 2021-12-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0415-2022

## Citation

> AI Analytics. FDA recall Z-0415-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0415-2022. Source: US FDA. Licensed CC0.

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