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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

No recalls linked.

Regulatory clearances
  • 510(k)K191281Substantially equivalent (SESE) · 2019-08-29clearance 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
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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