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.
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
Acclarent is recalling TruDi NAV Suction Instruments that may not be calibrated correctly, risking tissue damage or injury to critical structures during surgery. This affects specific model numbers and production lots.
The suction instruments may not be calibrated properly, which could lead to inaccurate visual verification of device location in the patient's anatomy. If the surgeon misses this error, it might cause tissue damage, carotid artery injury, CSF leaks, or optic nerve damage during surgery.
Surgeons using these suction instruments during procedures are most at risk. The recall applies to specific model types and production lots manufactured between 2019 and 2021.
Check for the model name (0-Degree, 70-Degree, or 90-Degree) and the reference code (TDNS000Z, TDNS070Z, or TDNS090Z). Affected units include specific production lots listed in the recall notice.
Identify the model (0-Degree, 70-Degree, or 90-Degree) and reference code (TDNS000Z, TDNS070Z, or TDNS090Z) on the instrument.
Compare the lot numbers listed in the recall notice to determine if your instrument is affected.
The recall affects TruDi NAV Suction Instruments: 0-Degree (REF: TDNS000Z), 70-Degree (REF: TDNS070Z), and 90-Degree (REF: TDNS090Z).
Check the model name and reference code on the instrument, then compare the lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Acclarent directly for guidance on next steps.
We’ve drafted a message you can send Acclarent to request your refund or repair — edit it as you like.
Subject: Recall Z-0415-2022 — Acclarent Acclarent Hello, I own a Acclarent that is covered by recall Z-0415-2022 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.
