TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

FDA Device Recall #Z-0825-2020 — Class II — March 6, 2019

Recall Summary

Recall Number Z-0825-2020
Classification Class II — Moderate risk
Date Initiated March 6, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Acclarent, Inc.
Location Irvine, CA
Product Type Devices

Product Description

TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

Reason for Recall

The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

Distribution Pattern

US: WI, IL, NE, CA, OH, NY OUS: None

Lot / Code Information

Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

Other Recalls from Acclarent, Inc.

Recall # Classification Product Date
Z-0127-2024 Class II TruDi Navigation System, Model: FG-2000-00, Cat... Sep 21, 2023
Z-0415-2022 Class II TruDi NAV Suction Instruments: 0-Degree, REF: T... Nov 12, 2021
Z-0824-2020 Class II TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle... Mar 6, 2019
Z-0826-2020 Class II TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angl... Mar 6, 2019
Z-1740-2015 Class III RELIEVA FLEX Sinus Guide Catheter F-70. Catalo... Apr 28, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.