Surgical Suction Instruments Recalled for Calibration Defect Risk
Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The potential harms are serious—arterial damage, nerve damage, CSF leak—making this a high-risk situation without yet-reported injury, per the rubric criterion for Score 3.
Plain-English summary
Acclarent, Inc. is recalling TruDi NAV Suction Instruments (0-Degree, 70-Degree, and 90-Degree models) due to a calibration error. A total of 1,543 units were distributed across the United States.
The affected instruments may not meet the system's accuracy specification for visual verification of device location during surgery. These instruments are used in surgical procedures where precise location tracking is critical.
If a surgeon does not detect the calibration error during the procedure, serious complications could occur, including tissue damage, damage to the carotid artery, cerebrospinal fluid (CSF) leak, or damage to the optic nerve. The error could also cause intraprocedural delay.
Patients who have received procedures using these instruments should consult their surgeon. Healthcare providers should identify affected instruments using the lot numbers provided and cease use of affected units.
The recalled product
- Product
- TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- Manufacturer
- Acclarent, Inc.
- Affected units
- 1,543
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 0-Degree Lots: 1903120
- 1903250
- 1904060
- 1904180
- 1904240
- 1905030
- 1905070
- 1906260
- 1907120
- 1907170
- 1907220
- 1907240
- 1907260
- 2003040
- 2009110
- 2011240
- 2102080
- 2103090
- 2104260
- 2105040
Distribution
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