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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.

  • European UnionACCULAN40392390000002962G
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.

2 linked reportsMalfunction 2
163147622019-01: 0 reports for this device; peer average 7.44/device2019-02: 0 reports for this device; peer average 7.8/device2019-03: 0 reports for this device; peer average 21/device2019-04: 0 reports for this device; peer average 5.71/device2019-05: 0 reports for this device; peer average 6.73/device2019-06: 0 reports for this device; peer average 6.3/device2019-07: 0 reports for this device; peer average 12.5/device2019-08: 0 reports for this device; peer average 7.93/device2019-09: 0 reports for this device; peer average 9.8/device2019-10: 0 reports for this device; peer average 10.9/device2019-11: 0 reports for this device; peer average 11.36/device2019-12: 0 reports for this device; peer average 16.25/device2020-01: 0 reports for this device; peer average 15.13/device2020-02: 0 reports for this device; peer average 12.13/device2020-03: 0 reports for this device; peer average 25.29/device2020-04: 0 reports for this device; peer average 11/device2020-05: 0 reports for this device; peer average 14.4/device2020-06: 0 reports for this device; peer average 22.8/device2020-07: 0 reports for this device; peer average 35.09/device2020-08: 0 reports for this device; peer average 34.87/device2020-09: 0 reports for this device; peer average 42.23/device2020-10: 0 reports for this device; peer average 62.11/device2020-11: 0 reports for this device; peer average 28.19/device2020-12: 0 reports for this device; peer average 40.09/device2021-01: 0 reports for this device; peer average 48.14/device2021-02: 0 reports for this device; peer average 47.63/device2021-03: 2 reports for this device; peer average 59.5/device2021-04: 0 reports for this device; peer average 54.5/device2021-05: 0 reports for this device; peer average 50.13/device2021-06: 0 reports for this device; peer average 16.15/device2021-07: 0 reports for this device; peer average 15.29/device2021-08: 0 reports for this device; peer average 10.08/device2021-09: 0 reports for this device; peer average 9.64/device2021-10: 0 reports for this device; peer average 24.2/device2021-11: 0 reports for this device; peer average 18.67/device2021-12: 0 reports for this device; peer average 28.4/device2022-01: 0 reports for this device; peer average 23/device2022-02: 0 reports for this device; peer average 24.33/device2022-03: 0 reports for this device; peer average 12.43/device2022-04: 0 reports for this device; peer average 9.67/device2022-05: 0 reports for this device; peer average 13.83/device2022-06: 0 reports for this device; peer average 11.44/device2022-07: 0 reports for this device; peer average 12/device2022-08: 0 reports for this device; peer average 13.17/device2022-09: 0 reports for this device; peer average 18.25/device2022-10: 0 reports for this device; peer average 12.44/device2022-11: 0 reports for this device; peer average 16.43/device2022-12: 0 reports for this device; peer average 13.63/device2023-01: 0 reports for this device; peer average 36/device2023-02: 0 reports for this device; peer average 16.2/device2023-03: 0 reports for this device; peer average 13.44/device2023-04: 0 reports for this device; peer average 15/device2023-05: 0 reports for this device; peer average 10.56/device2023-06: 0 reports for this device; peer average 57.5/device2023-07: 0 reports for this device; peer average 21.67/device2023-08: 0 reports for this device; peer average 22.71/device2023-09: 0 reports for this device; peer average 16.5/device2023-10: 0 reports for this device; peer average 10.91/device2023-11: 0 reports for this device; peer average 16.56/device2023-12: 0 reports for this device; peer average 8.87/device2024-01: 0 reports for this device; peer average 13.38/device2024-02: 0 reports for this device; peer average 8.85/device2024-03: 0 reports for this device; peer average 11.83/device2024-04: 0 reports for this device; peer average 11.93/device2024-05: 0 reports for this device; peer average 10.59/device2024-06: 0 reports for this device; peer average 9.9/device2024-07: 0 reports for this device; peer average 8/device2024-08: 0 reports for this device; peer average 6.15/device2024-09: 0 reports for this device; peer average 3.67/device2024-10: 0 reports for this device; peer average 5.14/device2024-11: 0 reports for this device; peer average 7/device2024-12: 0 reports for this device; peer average 6.58/device2025-01: 0 reports for this device; peer average 5.56/device2025-02: 0 reports for this device; peer average 5.86/device2025-03: 0 reports for this device; peer average 9.22/device2025-04: 0 reports for this device; peer average 4.85/device2025-05: 0 reports for this device; peer average 5.42/device2025-06: 0 reports for this device; peer average 4.5/device2025-07: 0 reports for this device; peer average 6.82/device2025-08: 0 reports for this device; peer average 4.38/device2025-09: 0 reports for this device; peer average 7.64/device2025-10: 0 reports for this device; peer average 8.78/device2025-11: 0 reports for this device; peer average 5.15/device2025-12: 0 reports for this device; peer average 4.82/device2026-01: 0 reports for this device; peer average 5.82/device2026-02: 0 reports for this device; peer average 8.3/device2026-03: 0 reports for this device; peer average 6.31/device2026-04: 0 reports for this device; peer average 5.42/device2026-05: 0 reports for this device; peer average 6.56/device2026-06: 0 reports for this device; peer average 7.18/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0107.44
2019-0207.8
2019-03021
2019-0405.71
2019-0506.73
2019-0606.3
2019-07012.5
2019-0807.93
2019-0909.8
2019-10010.9
2019-11011.36
2019-12016.25
2020-01015.13
2020-02012.13
2020-03025.29
2020-04011
2020-05014.4
2020-06022.8
2020-07035.09
2020-08034.87
2020-09042.23
2020-10062.11
2020-11028.19
2020-12040.09
2021-01048.14
2021-02047.63
2021-03259.5
2021-04054.5
2021-05050.13
2021-06016.15
2021-07015.29
2021-08010.08
2021-0909.64
2021-10024.2
2021-11018.67
2021-12028.4
2022-01023
2022-02024.33
2022-03012.43
2022-0409.67
2022-05013.83
2022-06011.44
2022-07012
2022-08013.17
2022-09018.25
2022-10012.44
2022-11016.43
2022-12013.63
2023-01036
2023-02016.2
2023-03013.44
2023-04015
2023-05010.56
2023-06057.5
2023-07021.67
2023-08022.71
2023-09016.5
2023-10010.91
2023-11016.56
2023-1208.87
2024-01013.38
2024-0208.85
2024-03011.83
2024-04011.93
2024-05010.59
2024-0609.9
2024-0708
2024-0806.15
2024-0903.67
2024-1005.14
2024-1107
2024-1206.58
2025-0105.56
2025-0205.86
2025-0309.22
2025-0404.85
2025-0505.42
2025-0604.5
2025-0706.82
2025-0804.38
2025-0907.64
2025-1008.78
2025-1105.15
2025-1204.82
2026-0105.82
2026-0208.3
2026-0306.31
2026-0405.42
2026-0506.56
2026-0607.18
This device (reports/month)Average device in HAB (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2021-03-109610612-2021-00168MalfunctionAvailablecatalog number

Showing the most recent 1 of 2 linked reports.

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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