Class II — Acclarent, Inc.
| Recalling firm | ACCLARENT, INC. |
|---|---|
| Registered facility | ACCLARENT, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z |
| Quantity | 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 |
| Initiated | 2021-11-12 |
| Classified | 2021-12-22 |
| Recall number | Z-0415-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Acclarent, Inc. (Z-0415-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89170/
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