Acclarent recalls TruDi NAV Suction instruments with calibration issues that show incorrect tip orientation. Affected lots have a 30-cycle reprocessing shelf life.
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 Tru:Di NAV Suction instruments that show incorrect tip orientation due to calibration issues. This could lead to improper use during medical procedures if the tip angle isn't displayed correctly.
The instruments display the wrong tip angle in the system due to calibration problems. This could cause improper positioning during medical procedures if the operator relies on the displayed angle for guidance.
Medical professionals using the TruDi NAV Suction instruments for procedures like endoscopy are most at risk. Patients using these instruments during surgery may be affected if the tip angle is misread.
Check for the model number TDNS070Z and lot numbers 1901080, 1901177, or 1901219. The instruments have a 30-cycle reprocessing shelf life.
Look for lot numbers 1901080, 1901177, or 1901219 on the instrument packaging.
The instruments display incorrect tip orientation in the system due to calibration problems.
Three lots: 1901080, 1901177, and 1901219.
The instruments have a shelf life of 30 reprocessing cycles.
We’ve drafted a message you can send Acclarent to request your refund or repair — edit it as you like.
Subject: Recall Z-0825-2020 — Acclarent Acclarent Hello, I own a Acclarent that is covered by recall Z-0825-2020 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.
