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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.

628 linked reportsInjury 411Malfunction 193Death 24
81523302019-01: 2 reports for this device; peer average 4/device2019-02: 2 reports for this device; peer average 2.58/device2019-03: 8 reports for this device; peer average 3.29/device2019-04: 4 reports for this device; peer average 4/device2019-05: 2 reports for this device; peer average 2.2/device2019-06: 2 reports for this device; peer average 5/device2019-07: 3 reports for this device; peer average 4.59/device2019-08: 6 reports for this device; peer average 3.42/device2019-09: 3 reports for this device; peer average 2.33/device2019-10: 6 reports for this device; peer average 3.5/device2019-11: 0 reports for this device; peer average 2.93/device2019-12: 5 reports for this device; peer average 4.27/device2020-01: 0 reports for this device; peer average 3.67/device2020-02: 12 reports for this device; peer average 4/device2020-03: 5 reports for this device; peer average 3.88/device2020-04: 0 reports for this device; peer average 3.27/device2020-05: 12 reports for this device; peer average 2.71/device2020-06: 0 reports for this device; peer average 5/device2020-07: 4 reports for this device; peer average 2.05/device2020-08: 0 reports for this device; peer average 2.67/device2020-09: 5 reports for this device; peer average 2.62/device2020-10: 4 reports for this device; peer average 4/device2020-11: 3 reports for this device; peer average 3.31/device2020-12: 4 reports for this device; peer average 4.33/device2021-01: 3 reports for this device; peer average 2.25/device2021-02: 5 reports for this device; peer average 4.14/device2021-03: 2 reports for this device; peer average 3.44/device2021-04: 8 reports for this device; peer average 3.8/device2021-05: 2 reports for this device; peer average 2.69/device2021-06: 9 reports for this device; peer average 6.18/device2021-07: 6 reports for this device; peer average 8/device2021-08: 5 reports for this device; peer average 4.26/device2021-09: 2 reports for this device; peer average 4.29/device2021-10: 8 reports for this device; peer average 5.75/device2021-11: 5 reports for this device; peer average 4.21/device2021-12: 12 reports for this device; peer average 5.58/device2022-01: 4 reports for this device; peer average 4.76/device2022-02: 6 reports for this device; peer average 3.06/device2022-03: 3 reports for this device; peer average 6.19/device2022-04: 6 reports for this device; peer average 4.15/device2022-05: 9 reports for this device; peer average 5/device2022-06: 0 reports for this device; peer average 2.13/device2022-07: 8 reports for this device; peer average 3.87/device2022-08: 11 reports for this device; peer average 3.42/device2022-09: 7 reports for this device; peer average 3.15/device2022-10: 6 reports for this device; peer average 3/device2022-11: 3 reports for this device; peer average 3.89/device2022-12: 8 reports for this device; peer average 11.2/device2023-01: 7 reports for this device; peer average 20.62/device2023-02: 3 reports for this device; peer average 9.35/device2023-03: 8 reports for this device; peer average 12.22/device2023-04: 20 reports for this device; peer average 13.21/device2023-05: 4 reports for this device; peer average 18.4/device2023-06: 9 reports for this device; peer average 18.95/device2023-07: 12 reports for this device; peer average 11.93/device2023-08: 9 reports for this device; peer average 11.5/device2023-09: 0 reports for this device; peer average 10.06/device2023-10: 9 reports for this device; peer average 10.82/device2023-11: 12 reports for this device; peer average 9.45/device2023-12: 4 reports for this device; peer average 11.69/device2024-01: 3 reports for this device; peer average 9.13/device2024-02: 3 reports for this device; peer average 11.61/device2024-03: 13 reports for this device; peer average 12.31/device2024-04: 2 reports for this device; peer average 10.69/device2024-05: 6 reports for this device; peer average 12.26/device2024-06: 14 reports for this device; peer average 9.57/device2024-07: 6 reports for this device; peer average 10.33/device2024-08: 0 reports for this device; peer average 11.61/device2024-09: 28 reports for this device; peer average 13.31/device2024-10: 7 reports for this device; peer average 10.49/device2024-11: 8 reports for this device; peer average 8.09/device2024-12: 6 reports for this device; peer average 12.53/device2025-01: 26 reports for this device; peer average 11.32/device2025-02: 0 reports for this device; peer average 12.94/device2025-03: 7 reports for this device; peer average 9.6/device2025-04: 10 reports for this device; peer average 10.36/device2025-05: 8 reports for this device; peer average 9.76/device2025-06: 11 reports for this device; peer average 9.05/device2025-07: 14 reports for this device; peer average 9.3/device2025-08: 5 reports for this device; peer average 9.82/device2025-09: 19 reports for this device; peer average 9.47/device2025-10: 14 reports for this device; peer average 8.89/device2025-11: 11 reports for this device; peer average 9.82/device2025-12: 8 reports for this device; peer average 9.93/device2026-01: 12 reports for this device; peer average 12.47/device2026-02: 4 reports for this device; peer average 17.64/device2026-03: 16 reports for this device; peer average 8.42/device2026-04: 10 reports for this device; peer average 8.76/device2026-05: 0 reports for this device; peer average 6.15/device2026-06: 30 reports for this device; peer average 8.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0124
2019-0222.58
2019-0383.29
2019-0444
2019-0522.2
2019-0625
2019-0734.59
2019-0863.42
2019-0932.33
2019-1063.5
2019-1102.93
2019-1254.27
2020-0103.67
2020-02124
2020-0353.88
2020-0403.27
2020-05122.71
2020-0605
2020-0742.05
2020-0802.67
2020-0952.62
2020-1044
2020-1133.31
2020-1244.33
2021-0132.25
2021-0254.14
2021-0323.44
2021-0483.8
2021-0522.69
2021-0696.18
2021-0768
2021-0854.26
2021-0924.29
2021-1085.75
2021-1154.21
2021-12125.58
2022-0144.76
2022-0263.06
2022-0336.19
2022-0464.15
2022-0595
2022-0602.13
2022-0783.87
2022-08113.42
2022-0973.15
2022-1063
2022-1133.89
2022-12811.2
2023-01720.62
2023-0239.35
2023-03812.22
2023-042013.21
2023-05418.4
2023-06918.95
2023-071211.93
2023-08911.5
2023-09010.06
2023-10910.82
2023-11129.45
2023-12411.69
2024-0139.13
2024-02311.61
2024-031312.31
2024-04210.69
2024-05612.26
2024-06149.57
2024-07610.33
2024-08011.61
2024-092813.31
2024-10710.49
2024-1188.09
2024-12612.53
2025-012611.32
2025-02012.94
2025-0379.6
2025-041010.36
2025-0589.76
2025-06119.05
2025-07149.3
2025-0859.82
2025-09199.47
2025-10148.89
2025-11119.82
2025-1289.93
2026-011212.47
2026-02417.64
2026-03168.42
2026-04108.76
2026-0506.15
2026-06308.38
This device (reports/month)Average device in HIH (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
2026-06-3025670027MalfunctionAvailablecatalog number
2026-06-251222780-2026-00404InjuryAvailablecatalog number
2026-06-231222780-2026-00401InjuryAvailablecatalog number
2026-06-2325592526MalfunctionAvailablecatalog number
2026-06-231222780-2026-00399Malfunction—catalog number
2026-06-091222780-2026-00365MalfunctionAvailablecatalog number
2026-06-091222780-2026-00368InjuryAvailablecatalog number
2026-06-091222780-2026-00367InjuryAvailablecatalog number
2026-04-301222780-2026-00194InjuryAvailableexact di
2026-04-111222780-2026-00166InjuryAvailablecatalog number
2026-04-111222780-2026-00167MalfunctionAvailablecatalog number
2026-03-311222780-2026-00154MalfunctionAvailablecatalog number
2026-03-31MW5186186MalfunctionAvailablemodel number
2026-03-301222780-2026-00147InjuryAvailablecatalog number
2026-03-131222780-2026-00115MalfunctionAvailableexact di

Showing the most recent 200 of 628 linked reports.

Showing 1–15 of 200
Regulatory clearances
  • 510(k)K152723Substantially equivalent (SESE) · 2015-11-13clearance family

Predicate lineage

Cited as predicate by: K172566, K201756

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
2025-11-04OAIOfficial action indicatedHologic, Inc3
2025-11-04OAIOfficial action indicatedHologic, Inc3
2024-12-18WLWarning LetterHologic, Inc—
2024-12-18WLWarning LetterHologic, Inc—
2024-09-24OAIOfficial action indicatedHologic, Inc5
2024-09-24OAIOfficial action indicatedHologic, Inc5
2024-09-12VAIVoluntary action indicatedHologic Surgical Products Costa Rica, S.R.L.0
2024-08-13NAINo action indicatedHologic, Inc.0
2024-08-13NAINo action indicatedHologic, Inc.0
2022-12-14NAINo action indicatedBolder Surgical, LLC0
2022-10-14OAIOfficial action indicatedHologic, Inc.4
2022-10-14OAIOfficial action indicatedHologic, Inc.4
2022-08-03VAIVoluntary action indicatedHealth Beacons, Inc.1
2020-02-25NAINo action indicatedHealth Beacons, Inc.0
2018-12-10NAINo action indicatedHologic, Inc.0
2018-12-10NAINo action indicatedHologic, Inc.0
2018-02-27NAINo action indicatedGynesonics, Inc.0
2017-11-30NAINo action indicatedHologic, Inc0
2017-11-30NAINo action indicatedHologic, Inc0
2017-11-27VAIVoluntary action indicatedBolder Surgical, LLC6
2017-10-25NAINo action indicatedHologic, Inc.0
2017-10-25NAINo action indicatedHologic, Inc.0
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