Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TruDi Navigation System Recalled by Acclarent, Inc. Due to When using affected curette and software, there is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Acclarent, Inc. directly.
Affected Products
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Quantity: 141
Why Was This Recalled?
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
Where Was This Sold?
This product was distributed to 30 states: AL, AZ, CA, CO, CT, FL, HI, ID, IL, IA, KS, LA, ME, MA, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, WI, DC
About Acclarent, Inc.
Acclarent, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report