Recall archive / FDA device enforcement
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z — FDA record Z-0415-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 12, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- 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.
- Classification
- Class II
- Recalling firm
- Acclarent, Inc.
- Quantity
- 1543
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0415-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 29, 2021
- Recall initiation date
- Nov 12, 2021
- Center classification date
- Dec 22, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.