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.
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Acclarent is recalling TruDi NAV Suction instruments that may show incorrect tip orientation due to calibration issues. This could lead to improper use during medical procedures. Affected units have specific lot numbers and are sold with a 30-cycle reprocessing limit.
The calibration issues cause the system to display the wrong tip angle, which could lead to improper placement during medical procedures. This might result in ineffective suction or unintended tissue damage if not corrected.
Healthcare professionals using the TruDi NAV Suction instruments for medical procedures are most at risk. Patients using these instruments during surgery may be affected if the tip orientation is incorrect.
Check the lot number on the instrument: 1901080, 1901177, or 1901219. The product is sold as TruDi NAV Suction with 0 Degree Tip Angle and model TDNS000Z.
Verify the tip orientation display matches the actual tip angle during use.
Lot numbers 1901080, 1901177, and 1901219.
Check the lot number on the instrument; affected lots are 1901080, 1901177, and 1901219.
The recall record does not mention a specific fix or remedy.
We’ve drafted a message you can send Acclarent to request your refund or repair — edit it as you like.
Subject: Recall Z-0824-2020 — Acclarent Acclarent Hello, I own a Acclarent that is covered by recall Z-0824-2020 from Acclarent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
