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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)K101797Substantially equivalent (SESE) · 2011-02-24clearance 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
2025-07-16NAINo action indicatedCovidien LLC0
2025-07-16NAINo action indicatedCovidien LLC0
2024-11-21NAINo action indicatedCovidien, LP0
2024-11-21NAINo action indicatedCovidien, LP0
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-09-08VAIVoluntary action indicatedCovidien0
2022-09-08VAIVoluntary action indicatedCovidien0
2022-04-28OAIOfficial action indicatedCovidien2
2022-04-28OAIOfficial action indicatedCovidien2
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2018-09-19NAINo action indicatedCovidien0
2018-09-19NAINo action indicatedCovidien0
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-08-09NAINo action indicatedCovidien0
2017-08-09NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2012-06-14WLWarning LetterCovidien, LP—
2012-06-14WLWarning LetterCovidien, LP—
2011-10-04WLWarning LetterOridion Medical 1987 Ltd.—
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