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.
153 linked reportsMalfunction 139Injury 14
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.75 |
| 2019-02 | 0 | 3 |
| 2019-03 | 0 | 4.67 |
| 2019-04 | 0 | 2.44 |
| 2019-05 | 0 | 22 |
| 2019-06 | 0 | 4.25 |
| 2019-07 | 4 | 6 |
| 2019-08 | 0 | 7 |
| 2019-09 | 0 | 2.2 |
| 2019-10 | 0 | 1.75 |
| 2019-11 | 0 | 1.25 |
| 2019-12 | 0 | 5 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 2.4 |
| 2020-03 | 0 | 6 |
| 2020-04 | 0 | 1.5 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.4 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 5 |
| 2020-09 | 0 | 1.33 |
| 2020-10 | 0 | 6 |
| 2020-11 | 0 | 1.5 |
| 2020-12 | 0 | 5 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 4.5 |
| 2021-03 | 0 | 8 |
| 2021-04 | 3 | 5.33 |
| 2021-05 | 0 | 10.5 |
| 2021-06 | 0 | 5 |
| 2021-07 | 3 | 6.67 |
| 2021-08 | 0 | 5.6 |
| 2021-09 | 0 | 3.2 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 3.67 |
| 2022-01 | 3 | 2.5 |
| 2022-02 | 3 | 3.75 |
| 2022-03 | 3 | 4.5 |
| 2022-04 | 3 | 3 |
| 2022-05 | 0 | 4.5 |
| 2022-06 | 6 | 2.89 |
| 2022-07 | 0 | 3.75 |
| 2022-08 | 0 | 3 |
| 2022-09 | 9 | 2.33 |
| 2022-10 | 0 | 5.5 |
| 2022-11 | 15 | 5.2 |
| 2022-12 | 0 | 2.25 |
| 2023-01 | 12 | 4.83 |
| 2023-02 | 6 | 2.67 |
| 2023-03 | 6 | 3.11 |
| 2023-04 | 6 | 3.5 |
| 2023-05 | 6 | 5.17 |
| 2023-06 | 3 | 3 |
| 2023-07 | 3 | 3.5 |
| 2023-08 | 0 | 3.8 |
| 2023-09 | 2 | 2.89 |
| 2023-10 | 2 | 2.5 |
| 2023-11 | 6 | 2.89 |
| 2023-12 | 4 | 4.11 |
| 2024-01 | 4 | 2 |
| 2024-02 | 0 | 3.25 |
| 2024-03 | 0 | 2.7 |
| 2024-04 | 6 | 4.09 |
| 2024-05 | 8 | 2.73 |
| 2024-06 | 2 | 2.33 |
| 2024-07 | 6 | 3 |
| 2024-08 | 0 | 6.67 |
| 2024-09 | 0 | 2 |
| 2024-10 | 2 | 4.6 |
| 2024-11 | 2 | 4.83 |
| 2024-12 | 0 | 3.8 |
| 2025-01 | 0 | 1.92 |
| 2025-02 | 10 | 4.65 |
| 2025-03 | 2 | 3.43 |
| 2025-04 | 0 | 1.93 |
| 2025-05 | 0 | 5.67 |
| 2025-06 | 0 | 8.5 |
| 2025-07 | 0 | 1.75 |
| 2025-08 | 0 | 4 |
| 2025-09 | 1 | 3 |
| 2025-10 | 0 | 2.4 |
| 2025-11 | 0 | 4.5 |
| 2025-12 | 2 | 2 |
| 2026-01 | 0 | 2.1 |
| 2026-02 | 0 | 2.33 |
| 2026-03 | 0 | 6.5 |
| 2026-04 | 0 | 1.38 |
| 2026-05 | 0 | 3 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-07-09 | Z-2507-2024 | Class II | Open, Classified | Specific 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 units | code info di |
| 2021-11-12 | Z-0415-2022 | Class II | Open, Classified | 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.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, ID | 1543 | clearance family |
| 2019-03-06 | Z-0824-2020 | Class II | Terminated | The 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: None | 14 Suction Insstruments | clearance family |
| 2019-03-06 | Z-0825-2020 | Class II | Terminated | The 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: None | clearance family | |
| 2019-03-06 | Z-0826-2020 | Class II | Terminated | The 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: None | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-10 | 3003418325-2025-00067 | Malfunction | Available | catalog number |
| 2025-09-22 | 3003418325-2025-00055 | Malfunction | Available | catalog number |
| 2025-03-25 | 3005172759-2025-00027 | Malfunction | Available | catalog number |
| 2025-02-24 | 3005172759-2025-00006 | Injury | Available | catalog number |
| 2025-02-24 | 3005172759-2025-00019 | Malfunction | Available | catalog number |
| 2025-02-12 | 3005172759-2025-00009 | Malfunction | Available | catalog number |
| 2025-02-12 | 3005172759-2025-00008 | Malfunction | Available | exact di |
| 2025-02-12 | 3005172759-2025-00012 | Injury | Available | catalog number |
| 2025-02-07 | 3005172759-2025-00003 | Malfunction | Available | catalog number |
| 2024-11-07 | 3005172759-2024-00092 | Malfunction | Available | catalog number |
| 2024-10-02 | 3005172759-2024-00089 | Malfunction | Available | catalog number |
| 2024-07-19 | 3005172759-2024-00075 | Malfunction | Available | catalog number |
| 2024-07-19 | 3005172759-2024-00076 | Malfunction | Available | catalog number |
| 2024-07-01 | 3005172759-2024-00072 | Malfunction | Available | catalog number |
| 2024-06-03 | 3005172759-2024-00066 | Malfunction | Available | catalog number |
Showing the most recent 63 of 153 linked reports.
Showing 1–15 of 63
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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2020-09-25 | NAI | No action indicated | Acclarent, Inc. | 0 |
| 2020-09-25 | NAI | No action indicated | Acclarent, Inc. | 0 |
| 2013-12-09 | VAI | Voluntary action indicated | Acclarent, Inc. | 0 |
| 2013-12-09 | VAI | Voluntary action indicated | Acclarent, Inc. | 0 |
| 2013-03-20 | WL | Warning Letter | Acclarent, Inc. | — |
| 2013-03-20 | WL | Warning Letter | Acclarent, Inc. | — |
| 2013-02-22 | OAI | Official action indicated | Acclarent, Inc. | 2 |
| 2013-02-22 | OAI | Official action indicated | Acclarent, Inc. | 2 |
| 2012-06-14 | WL | Warning Letter | Acclarent, Inc. | — |
| 2012-06-14 | WL | Warning Letter | Acclarent, Inc. | — |
| 2012-02-24 | OAI | Official action indicated | Acclarent, Inc. | 3 |
| 2012-02-24 | OAI | Official action indicated | Acclarent, Inc. | 3 |
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