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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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.

15 linked reportsInjury 10Malfunction 5
12232020-10: 3 reports for this device2021-03: 2 reports for this device2021-04: 2 reports for this device2021-08: 2 reports for this device2021-10: 1 reports for this device2021-11: 1 reports for this device2022-09: 1 reports for this device2023-09: 1 reports for this device2024-05: 1 reports for this device2024-09: 1 reports for this device10030408101109090509
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-103—
2021-032—
2021-042—
2021-082—
2021-101—
2021-111—
2022-091—
2023-091—
2024-051—
2024-091—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-09-272916714-2024-00144InjuryAvailableexact di
2024-05-212916714-2024-00084InjuryAvailableexact di
2023-09-192916714-2023-00088InjuryAvailableexact di
2022-09-309610612-2022-00265MalfunctionAvailableexact di
2021-11-229610612-2021-00731MalfunctionAvailableexact di
2021-10-199610612-2021-00657MalfunctionAvailableexact di
2021-08-249610612-2021-00577MalfunctionAvailableexact di
2021-08-049610612-2021-00533MalfunctionAvailableexact di
2021-04-212916714-2021-00065InjuryAvailableexact di
2021-04-199610612-2021-00317InjuryAvailableexact di
2021-03-242916714-2021-00041InjuryAvailableexact di
2021-03-249610612-2021-00219InjuryAvailableexact di
2020-10-302916714-2020-00649InjuryAvailableexact di
2020-10-309610612-2020-00758InjuryAvailableexact di
2020-10-062916714-2020-00541InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-11NAINo action indicatedAesculap Inc0
2025-07-11NAINo action indicatedAesculap Inc0
2022-07-21NAINo action indicatedAesculap AG0
2022-07-21NAINo action indicatedAesculap AG0
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2015-07-16NAINo action indicatedAesculap AG1
2015-07-16NAINo action indicatedAesculap AG1
2015-05-05NAINo action indicatedAesculap Inc0
2015-05-05NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2011-09-26WLWarning LetterAesculap AG—
2011-09-26WLWarning LetterAesculap AG—
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