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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.

10,189 linked reportsMalfunction 9,923Injury 253Death 13
771532303062019-01: 95 reports for this device; peer average 12.92/device2019-02: 85 reports for this device; peer average 14.35/device2019-03: 106 reports for this device; peer average 14.05/device2019-04: 134 reports for this device; peer average 18.63/device2019-05: 131 reports for this device; peer average 19.54/device2019-06: 144 reports for this device; peer average 20.19/device2019-07: 108 reports for this device; peer average 13.37/device2019-08: 79 reports for this device; peer average 11.15/device2019-09: 72 reports for this device; peer average 11.95/device2019-10: 68 reports for this device; peer average 9.58/device2019-11: 83 reports for this device; peer average 11.88/device2019-12: 96 reports for this device; peer average 14.46/device2020-01: 72 reports for this device; peer average 11.27/device2020-02: 94 reports for this device; peer average 12.22/device2020-03: 105 reports for this device; peer average 12.88/device2020-04: 65 reports for this device; peer average 10.44/device2020-05: 77 reports for this device; peer average 15.5/device2020-06: 71 reports for this device; peer average 12.21/device2020-07: 66 reports for this device; peer average 14.34/device2020-08: 69 reports for this device; peer average 12.98/device2020-09: 59 reports for this device; peer average 12.31/device2020-10: 80 reports for this device; peer average 12.61/device2020-11: 82 reports for this device; peer average 14.12/device2020-12: 93 reports for this device; peer average 12.64/device2021-01: 75 reports for this device; peer average 11.89/device2021-02: 84 reports for this device; peer average 14.14/device2021-03: 94 reports for this device; peer average 13.25/device2021-04: 87 reports for this device; peer average 13.21/device2021-05: 81 reports for this device; peer average 14.8/device2021-06: 97 reports for this device; peer average 18.26/device2021-07: 77 reports for this device; peer average 13.79/device2021-08: 83 reports for this device; peer average 17.29/device2021-09: 95 reports for this device; peer average 24.68/device2021-10: 75 reports for this device; peer average 14.32/device2021-11: 76 reports for this device; peer average 16.72/device2021-12: 82 reports for this device; peer average 12.67/device2022-01: 51 reports for this device; peer average 10.59/device2022-02: 59 reports for this device; peer average 13.53/device2022-03: 82 reports for this device; peer average 15.09/device2022-04: 70 reports for this device; peer average 12.75/device2022-05: 82 reports for this device; peer average 16.55/device2022-06: 81 reports for this device; peer average 15.68/device2022-07: 70 reports for this device; peer average 12.74/device2022-08: 93 reports for this device; peer average 13.73/device2022-09: 68 reports for this device; peer average 15.67/device2022-10: 95 reports for this device; peer average 18.18/device2022-11: 79 reports for this device; peer average 16.94/device2022-12: 91 reports for this device; peer average 16.56/device2023-01: 65 reports for this device; peer average 14/device2023-02: 68 reports for this device; peer average 12.62/device2023-03: 99 reports for this device; peer average 16.68/device2023-04: 89 reports for this device; peer average 14.38/device2023-05: 112 reports for this device; peer average 16.67/device2023-06: 132 reports for this device; peer average 24.22/device2023-07: 138 reports for this device; peer average 25.39/device2023-08: 145 reports for this device; peer average 21.23/device2023-09: 116 reports for this device; peer average 17.03/device2023-10: 137 reports for this device; peer average 17.29/device2023-11: 134 reports for this device; peer average 18.43/device2023-12: 145 reports for this device; peer average 20.54/device2024-01: 156 reports for this device; peer average 25.65/device2024-02: 161 reports for this device; peer average 20.49/device2024-03: 164 reports for this device; peer average 21.69/device2024-04: 144 reports for this device; peer average 22.32/device2024-05: 147 reports for this device; peer average 18.44/device2024-06: 104 reports for this device; peer average 19.81/device2024-07: 152 reports for this device; peer average 23.6/device2024-08: 279 reports for this device; peer average 29.73/device2024-09: 203 reports for this device; peer average 22.75/device2024-10: 255 reports for this device; peer average 27.4/device2024-11: 161 reports for this device; peer average 14.37/device2024-12: 159 reports for this device; peer average 16.74/device2025-01: 180 reports for this device; peer average 16.27/device2025-02: 306 reports for this device; peer average 21.38/device2025-03: 189 reports for this device; peer average 25.24/device2025-04: 208 reports for this device; peer average 23.34/device2025-05: 207 reports for this device; peer average 20.44/device2025-06: 255 reports for this device; peer average 33.41/device2025-07: 160 reports for this device; peer average 20.35/device2025-08: 129 reports for this device; peer average 17.63/device2025-09: 153 reports for this device; peer average 19.99/device2025-10: 152 reports for this device; peer average 18.6/device2025-11: 126 reports for this device; peer average 16.83/device2025-12: 104 reports for this device; peer average 15.93/device2026-01: 117 reports for this device; peer average 17/device2026-02: 75 reports for this device; peer average 14.12/device2026-03: 102 reports for this device; peer average 15.06/device2026-04: 84 reports for this device; peer average 11.52/device2026-05: 61 reports for this device; peer average 11.51/device2026-06: 55 reports for this device; peer average 8.95/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-019512.92
2019-028514.35
2019-0310614.05
2019-0413418.63
2019-0513119.54
2019-0614420.19
2019-0710813.37
2019-087911.15
2019-097211.95
2019-10689.58
2019-118311.88
2019-129614.46
2020-017211.27
2020-029412.22
2020-0310512.88
2020-046510.44
2020-057715.5
2020-067112.21
2020-076614.34
2020-086912.98
2020-095912.31
2020-108012.61
2020-118214.12
2020-129312.64
2021-017511.89
2021-028414.14
2021-039413.25
2021-048713.21
2021-058114.8
2021-069718.26
2021-077713.79
2021-088317.29
2021-099524.68
2021-107514.32
2021-117616.72
2021-128212.67
2022-015110.59
2022-025913.53
2022-038215.09
2022-047012.75
2022-058216.55
2022-068115.68
2022-077012.74
2022-089313.73
2022-096815.67
2022-109518.18
2022-117916.94
2022-129116.56
2023-016514
2023-026812.62
2023-039916.68
2023-048914.38
2023-0511216.67
2023-0613224.22
2023-0713825.39
2023-0814521.23
2023-0911617.03
2023-1013717.29
2023-1113418.43
2023-1214520.54
2024-0115625.65
2024-0216120.49
2024-0316421.69
2024-0414422.32
2024-0514718.44
2024-0610419.81
2024-0715223.6
2024-0827929.73
2024-0920322.75
2024-1025527.4
2024-1116114.37
2024-1215916.74
2025-0118016.27
2025-0230621.38
2025-0318925.24
2025-0420823.34
2025-0520720.44
2025-0625533.41
2025-0716020.35
2025-0812917.63
2025-0915319.99
2025-1015218.6
2025-1112616.83
2025-1210415.93
2026-0111717
2026-027514.12
2026-0310215.06
2026-048411.52
2026-056111.51
2026-06558.95
This device (reports/month)Average device in HAW (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-301723170-2026-00937Malfunction—model number
2026-06-291723170-2026-00933Malfunction—model number
2026-06-291723170-2026-00932Malfunction—model number
2026-06-291723170-2026-00936MalfunctionAvailablemodel number
2026-06-261723170-2026-00931Malfunction—model number
2026-06-251723170-2026-00929Malfunction—model number
2026-06-251723170-2026-00926Malfunction—model number
2026-06-241723170-2026-00914Malfunction—model number
2026-06-241723170-2026-00924Malfunction—model number
2026-06-241723170-2026-00917MalfunctionAvailablemodel number
2026-06-241723170-2026-00918Malfunction—model number
2026-06-231723170-2026-00911Malfunction—model number
2026-06-221723170-2026-00910Malfunction—model number
2026-06-221723170-2026-00908Malfunction—model number
2026-06-191723170-2026-00906Malfunction—model number

Showing the most recent 200 of 10,189 linked reports.

Showing 1–15 of 200
Regulatory clearances

    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
    2024-02-09VAIVoluntary action indicatedMedtronic Navigation, Inc.3
    2021-06-29VAIVoluntary action indicatedMedtronic Navigation, Inc.3
    2019-09-30VAIVoluntary action indicatedMedtronic Navigation, Inc.1
    2016-08-18VAIVoluntary action indicatedMedtronic Navigation, Inc.0
    2014-12-15NAINo action indicatedMedtronic Navigation, Inc.0
    2014-02-19VAIVoluntary action indicatedMedtronic Navigation, Inc.5
    2012-09-06NAINo action indicatedMedtronic Navigation, Inc.0
    2012-05-01NAINo action indicatedMedtronic Navigation, Inc.0
    2011-03-24VAIVoluntary action indicatedMedtronic Navigation, Inc.1
    2010-05-07WLWarning LetterMedtronic Navigation, Inc.—
    2010-02-04OAIOfficial action indicatedMedtronic Navigation, Inc.9
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