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TruDi NAV Suction

Model TDNS000Z · ACCLARENT, INC. · DI 10705031245877

PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (5)

InitiatedRecall #ClassStatusReasonLink 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.code info di
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.k number procode
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.k number procode
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.k number procode
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.k number procode

Adverse-event reports — MAUDE (153)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 139 · Injury: 14

61117222019-01: 0 reports for this device; peer average 2.75/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 4.67/device2019-04: 0 reports for this device; peer average 2.44/device2019-05: 0 reports for this device; peer average 22/device2019-06: 0 reports for this device; peer average 4.25/device2019-07: 4 reports for this device; peer average 6/device2019-08: 0 reports for this device; peer average 7/device2019-09: 0 reports for this device; peer average 2.2/device2019-10: 0 reports for this device; peer average 1.75/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 5/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 2.4/device2020-03: 0 reports for this device; peer average 6/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.4/device2020-07: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 5/device2020-09: 0 reports for this device; peer average 1.33/device2020-10: 0 reports for this device; peer average 6/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 5/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 4.5/device2021-03: 0 reports for this device; peer average 8/device2021-04: 3 reports for this device; peer average 5.33/device2021-05: 0 reports for this device; peer average 10.5/device2021-06: 0 reports for this device; peer average 5/device2021-07: 3 reports for this device; peer average 6.67/device2021-08: 0 reports for this device; peer average 5.6/device2021-09: 0 reports for this device; peer average 3.2/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3.67/device2022-01: 3 reports for this device; peer average 2.5/device2022-02: 3 reports for this device; peer average 3.75/device2022-03: 3 reports for this device; peer average 4.5/device2022-04: 3 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 4.5/device2022-06: 6 reports for this device; peer average 2.89/device2022-07: 0 reports for this device; peer average 3.75/device2022-08: 0 reports for this device; peer average 3/device2022-09: 9 reports for this device; peer average 2.33/device2022-10: 0 reports for this device; peer average 5.5/device2022-11: 15 reports for this device; peer average 5.2/device2022-12: 0 reports for this device; peer average 2.25/device2023-01: 12 reports for this device; peer average 4.83/device2023-02: 6 reports for this device; peer average 2.67/device2023-03: 6 reports for this device; peer average 3.11/device2023-04: 6 reports for this device; peer average 3.5/device2023-05: 6 reports for this device; peer average 5.17/device2023-06: 3 reports for this device; peer average 3/device2023-07: 3 reports for this device; peer average 3.5/device2023-08: 0 reports for this device; peer average 3.8/device2023-09: 2 reports for this device; peer average 2.89/device2023-10: 2 reports for this device; peer average 2.5/device2023-11: 6 reports for this device; peer average 2.89/device2023-12: 4 reports for this device; peer average 4.11/device2024-01: 4 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 3.25/device2024-03: 0 reports for this device; peer average 2.7/device2024-04: 6 reports for this device; peer average 4.09/device2024-05: 8 reports for this device; peer average 2.73/device2024-06: 2 reports for this device; peer average 2.33/device2024-07: 6 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 6.67/device2024-09: 0 reports for this device; peer average 2/device2024-10: 2 reports for this device; peer average 4.6/device2024-11: 2 reports for this device; peer average 4.83/device2024-12: 0 reports for this device; peer average 3.8/device2025-01: 0 reports for this device; peer average 1.92/device2025-02: 10 reports for this device; peer average 4.65/device2025-03: 2 reports for this device; peer average 3.43/device2025-04: 0 reports for this device; peer average 1.93/device2025-05: 0 reports for this device; peer average 5.67/device2025-06: 0 reports for this device; peer average 8.5/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 4/device2025-09: 1 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 2.4/device2025-11: 0 reports for this device; peer average 4.5/device2025-12: 2 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2.1/device2026-02: 0 reports for this device; peer average 2.33/device2026-03: 0 reports for this device; peer average 6.5/device2026-04: 0 reports for this device; peer average 1.38/device2026-05: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.75
2019-0203
2019-0304.67
2019-0402.44
2019-05022
2019-0604.25
2019-0746
2019-0807
2019-0902.2
2019-1001.75
2019-1101.25
2019-1205
2020-0101.5
2020-0202.4
2020-0306
2020-0401.5
2020-0502
2020-0602.4
2020-0703
2020-0805
2020-0901.33
2020-1006
2020-1101.5
2020-1205
2021-0103
2021-0204.5
2021-0308
2021-0435.33
2021-05010.5
2021-0605
2021-0736.67
2021-0805.6
2021-0903.2
2021-1003
2021-1103
2021-1203.67
2022-0132.5
2022-0233.75
2022-0334.5
2022-0433
2022-0504.5
2022-0662.89
2022-0703.75
2022-0803
2022-0992.33
2022-1005.5
2022-11155.2
2022-1202.25
2023-01124.83
2023-0262.67
2023-0363.11
2023-0463.5
2023-0565.17
2023-0633
2023-0733.5
2023-0803.8
2023-0922.89
2023-1022.5
2023-1162.89
2023-1244.11
2024-0142
2024-0203.25
2024-0302.7
2024-0464.09
2024-0582.73
2024-0622.33
2024-0763
2024-0806.67
2024-0902
2024-1024.6
2024-1124.83
2024-1203.8
2025-0101.92
2025-02104.65
2025-0323.43
2025-0401.93
2025-0505.67
2025-0608.5
2025-0701.75
2025-0804
2025-0913
2025-1002.4
2025-1104.5
2025-1222
2026-0102.1
2026-0202.33
2026-0306.5
2026-0401.38
2026-0503
2026-0602
This device (reports/month)Average device in PGW (reports/device/month)

Regulatory clearances

  • K180948 SESE 2018-07-20 (k number procode)

Predicate lineage

K180948 — cites (transitively): K153555 (d1), K161555 (d1), K173628 (d1), K001284 (d2), K050438 (d2), K122096 (d2), K133573 (d2), K161701 (d2), K014256 (d3), K960330 (d3), K964229 (d3), K983529 (d3), K133916 (d3), K130721 (d4)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — ACCLARENT, INC.

  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations