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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.

33 linked reportsMalfunction 28Injury 5
61117222019-01: 2 reports for this device; peer average 2/device2019-10: 22 reports for this device; peer average 22/device2021-04: 2 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-12: 5 reports for this device; peer average 5/device2024-02: 2 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device011004070903090712020205
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0122
2019-102222
2021-0422
2021-0701
2021-0901
2022-0301
2022-0901
2023-0701
2023-1255
2024-0222
2025-0201
2025-0502
This device (reports/month)Average device in HBO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-02-0118621475MalfunctionAvailablecatalog number
2023-12-112916714-2023-00131InjuryAvailablecatalog number
2023-12-069610612-2023-00266InjuryAvailablecatalog number
2021-04-159610612-2021-00352MalfunctionAvailablecatalog number
2019-10-029610612-2019-00685MalfunctionAvailablecatalog number
2019-10-029610612-2019-00682MalfunctionAvailablecatalog number
2019-10-029610612-2019-00677MalfunctionAvailablecatalog number
2019-10-029610612-2019-00679MalfunctionAvailablecatalog number
2019-10-029610612-2019-00684MalfunctionAvailablecatalog number
2019-10-029610612-2019-00683MalfunctionAvailablecatalog number
2019-10-029610612-2019-00681MalfunctionAvailablecatalog number
2019-10-029610612-2019-00680MalfunctionAvailablecatalog number
2019-10-029610612-2019-00676MalfunctionAvailablecatalog number
2019-10-029610612-2019-00678MalfunctionAvailablecatalog number
2019-10-029610612-2019-00686MalfunctionAvailablecatalog number

Showing the most recent 16 of 33 linked reports.

Showing 1–15 of 16
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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