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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.

126 linked reportsMalfunction 81Injury 45
71420272019-01: 0 reports for this device; peer average 2.43/device2019-02: 4 reports for this device; peer average 2.31/device2019-03: 2 reports for this device; peer average 2.25/device2019-04: 8 reports for this device; peer average 2.08/device2019-05: 0 reports for this device; peer average 2.21/device2019-06: 2 reports for this device; peer average 2.28/device2019-07: 0 reports for this device; peer average 2.37/device2019-08: 0 reports for this device; peer average 2.23/device2019-09: 2 reports for this device; peer average 2.68/device2019-10: 0 reports for this device; peer average 2.1/device2019-11: 0 reports for this device; peer average 2.09/device2019-12: 10 reports for this device; peer average 2.29/device2020-01: 0 reports for this device; peer average 2.34/device2020-02: 2 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.14/device2020-04: 6 reports for this device; peer average 2.25/device2020-05: 2 reports for this device; peer average 2.09/device2020-06: 0 reports for this device; peer average 2.65/device2020-07: 2 reports for this device; peer average 3.62/device2020-08: 2 reports for this device; peer average 3.36/device2020-09: 27 reports for this device; peer average 3.49/device2020-10: 10 reports for this device; peer average 4.02/device2020-11: 2 reports for this device; peer average 3.63/device2020-12: 6 reports for this device; peer average 3.57/device2021-01: 0 reports for this device; peer average 3.73/device2021-02: 2 reports for this device; peer average 3.67/device2021-03: 16 reports for this device; peer average 3.23/device2021-04: 6 reports for this device; peer average 3.49/device2021-05: 2 reports for this device; peer average 3.18/device2021-06: 0 reports for this device; peer average 3.03/device2021-07: 0 reports for this device; peer average 2.66/device2021-08: 0 reports for this device; peer average 3.22/device2021-09: 3 reports for this device; peer average 2.79/device2021-10: 0 reports for this device; peer average 2.52/device2021-11: 0 reports for this device; peer average 3.11/device2021-12: 0 reports for this device; peer average 2.67/device2022-01: 0 reports for this device; peer average 2.6/device2022-02: 0 reports for this device; peer average 3.13/device2022-03: 0 reports for this device; peer average 3.17/device2022-04: 0 reports for this device; peer average 3.52/device2022-05: 0 reports for this device; peer average 3.71/device2022-06: 0 reports for this device; peer average 2.82/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 0 reports for this device; peer average 2.59/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.08/device2022-11: 0 reports for this device; peer average 3.6/device2022-12: 0 reports for this device; peer average 3.74/device2023-01: 0 reports for this device; peer average 4.57/device2023-02: 0 reports for this device; peer average 3.11/device2023-03: 2 reports for this device; peer average 3.63/device2023-04: 0 reports for this device; peer average 3.08/device2023-05: 0 reports for this device; peer average 3.19/device2023-06: 2 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.85/device2023-08: 0 reports for this device; peer average 2.89/device2023-09: 0 reports for this device; peer average 2.22/device2023-10: 0 reports for this device; peer average 2.4/device2023-11: 0 reports for this device; peer average 3.21/device2023-12: 0 reports for this device; peer average 3.04/device2024-01: 0 reports for this device; peer average 2.84/device2024-02: 0 reports for this device; peer average 3.03/device2024-03: 0 reports for this device; peer average 2.79/device2024-04: 0 reports for this device; peer average 3.59/device2024-05: 0 reports for this device; peer average 3.57/device2024-06: 0 reports for this device; peer average 3.68/device2024-07: 0 reports for this device; peer average 2.83/device2024-08: 0 reports for this device; peer average 2.74/device2024-09: 0 reports for this device; peer average 3.06/device2024-10: 0 reports for this device; peer average 3.11/device2024-11: 0 reports for this device; peer average 2.81/device2024-12: 0 reports for this device; peer average 2.56/device2025-01: 0 reports for this device; peer average 2.86/device2025-02: 0 reports for this device; peer average 4.24/device2025-03: 0 reports for this device; peer average 5.06/device2025-04: 0 reports for this device; peer average 2.79/device2025-05: 0 reports for this device; peer average 2.85/device2025-06: 0 reports for this device; peer average 2.78/device2025-07: 2 reports for this device; peer average 2.56/device2025-08: 0 reports for this device; peer average 2.6/device2025-09: 0 reports for this device; peer average 2.15/device2025-10: 0 reports for this device; peer average 2.32/device2025-11: 2 reports for this device; peer average 2.66/device2025-12: 0 reports for this device; peer average 3.79/device2026-01: 2 reports for this device; peer average 3.54/device2026-02: 0 reports for this device; peer average 3.48/device2026-03: 0 reports for this device; peer average 3.22/device2026-04: 0 reports for this device; peer average 3.13/device2026-05: 0 reports for this device; peer average 2.6/device2026-06: 0 reports for this device; peer average 3.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0242.31
2019-0322.25
2019-0482.08
2019-0502.21
2019-0622.28
2019-0702.37
2019-0802.23
2019-0922.68
2019-1002.1
2019-1102.09
2019-12102.29
2020-0102.34
2020-0222.07
2020-0302.14
2020-0462.25
2020-0522.09
2020-0602.65
2020-0723.62
2020-0823.36
2020-09273.49
2020-10104.02
2020-1123.63
2020-1263.57
2021-0103.73
2021-0223.67
2021-03163.23
2021-0463.49
2021-0523.18
2021-0603.03
2021-0702.66
2021-0803.22
2021-0932.79
2021-1002.52
2021-1103.11
2021-1202.67
2022-0102.6
2022-0203.13
2022-0303.17
2022-0403.52
2022-0503.71
2022-0602.82
2022-0702.5
2022-0802.59
2022-0902.82
2022-1003.08
2022-1103.6
2022-1203.74
2023-0104.57
2023-0203.11
2023-0323.63
2023-0403.08
2023-0503.19
2023-0623.19
2023-0702.85
2023-0802.89
2023-0902.22
2023-1002.4
2023-1103.21
2023-1203.04
2024-0102.84
2024-0203.03
2024-0302.79
2024-0403.59
2024-0503.57
2024-0603.68
2024-0702.83
2024-0802.74
2024-0903.06
2024-1003.11
2024-1102.81
2024-1202.56
2025-0102.86
2025-0204.24
2025-0305.06
2025-0402.79
2025-0502.85
2025-0602.78
2025-0722.56
2025-0802.6
2025-0902.15
2025-1002.32
2025-1122.66
2025-1203.79
2026-0123.54
2026-0203.48
2026-0303.22
2026-0403.13
2026-0502.6
2026-0603.35
This device (reports/month)Average device in LXH (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
2026-01-229610612-2026-00006MalfunctionAvailablecatalog number
2025-11-189610612-2025-00282InjuryAvailablecatalog number
2025-07-159610612-2025-00140MalfunctionAvailablecatalog number
2023-06-279610612-2023-00160InjuryAvailablecatalog number
2023-03-219610612-2023-00064InjuryAvailablecatalog number
2021-09-309610612-2021-00658InjuryAvailablecatalog number
2021-05-119610612-2021-00360InjuryAvailablecatalog number
2021-04-162916714-2021-00052InjuryAvailablecatalog number
2021-04-079610612-2021-00290InjuryAvailablecatalog number
2021-03-299610612-2021-00274MalfunctionAvailablecatalog number
2021-03-299610612-2021-00273MalfunctionAvailablecatalog number
2021-03-249610612-2021-00282InjuryAvailablecatalog number
2021-03-249610612-2021-00240InjuryAvailablecatalog number
2021-03-129610612-2021-00222InjuryAvailablecatalog number
2021-03-109610612-2021-00236MalfunctionAvailablecatalog number

Showing the most recent 60 of 126 linked reports.

Showing 1–15 of 60
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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