Every recall we track for Acclarent, Inc. — 5 in all — plus the complaints and injury reports the public filed about them.
Acclarent recalls TruDi Navigation System (FG-2000-00) used with specific curettes due to location mismatch during ENT surgery, risking prolonged procedures, CSF leaks, or structural damage. Affected units sold with certain software versions.
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.
Acclarent recalls TruDi NAV Suction instruments with calibration issues causing incorrect tip orientation display. Affected lots: 1901080, 1901177, 1901219. No immediate action needed but check for calibration errors.
Acclarent recalls TruDi NAV Suction instruments with calibration issues causing incorrect tip orientation display. Affected lots: 1901080, 1901177, 1901219. No immediate action needed but check for calibration issues.
Acclarent recalls TruDi NAV Suction instruments with calibration issues that show incorrect tip orientation. Affected lots have a 30-cycle reprocessing shelf life.
