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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-07-09Z-2507-2024Class IIOpen, ClassifiedSpecific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.Distribution: The devices are only sold in the US. The following states have received the product: AL, AZ CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, VA, VT, WI.265 unitsclearance family
2021-11-12Z-0415-2022Class IIOpen, ClassifiedSuction 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.Distribution: US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID1543clearance family
2019-03-06Z-0824-2020Class IITerminatedThe firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.Distribution: US: WI, IL, NE, CA, OH, NY OUS: None14 Suction Insstrumentsclearance family
2019-03-06Z-0825-2020Class IITerminatedThe firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.Distribution: US: WI, IL, NE, CA, OH, NY OUS: Noneclearance family
2019-03-06Z-0826-2020Class IITerminatedThe firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.Distribution: US: WI, IL, NE, CA, OH, NY OUS: Noneclearance family
Regulatory clearances
  • 510(k)K180948Substantially equivalent (SESE) · 2018-07-20clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2020-09-25NAINo action indicatedAcclarent, Inc.0
2020-09-25NAINo action indicatedAcclarent, Inc.0
2013-12-09VAIVoluntary action indicatedAcclarent, Inc.0
2013-12-09VAIVoluntary action indicatedAcclarent, Inc.0
2013-03-20WLWarning LetterAcclarent, Inc.—
2013-03-20WLWarning LetterAcclarent, Inc.—
2013-02-22OAIOfficial action indicatedAcclarent, Inc.2
2013-02-22OAIOfficial action indicatedAcclarent, Inc.2
2012-06-14WLWarning LetterAcclarent, Inc.—
2012-06-14WLWarning LetterAcclarent, Inc.—
2012-02-24OAIOfficial action indicatedAcclarent, Inc.3
2012-02-24OAIOfficial action indicatedAcclarent, Inc.3
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