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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.

3 linked reportsMalfunction 3
4812162019-05: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 15.5/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 5/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 2.67/device2021-10: 0 reports for this device; peer average 2/device2021-11: 3 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2.67/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2.33/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 3.29/device2022-09: 0 reports for this device; peer average 2.11/device2022-10: 0 reports for this device; peer average 1.6/device2022-11: 0 reports for this device; peer average 2.5/device2022-12: 0 reports for this device; peer average 2.25/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.67/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1.75/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1.71/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.25/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.33/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2.5/device2025-02: 0 reports for this device; peer average 2.43/device2025-03: 0 reports for this device; peer average 1.8/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 3.4/device2025-10: 0 reports for this device; peer average 1.4/device2025-11: 0 reports for this device; peer average 2.67/device2025-12: 0 reports for this device; peer average 2.2/device2026-01: 0 reports for this device; peer average 2.33/device2026-02: 0 reports for this device; peer average 2.25/device2026-03: 0 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 2.17/device2026-05: 0 reports for this device; peer average 2.86/device2026-06: 0 reports for this device; peer average 2/device0501030506081112030405060809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2020-0101
2020-0302
2020-0502
2020-0604
2020-0804
2020-1103
2020-12015.5
2021-0302
2021-0401
2021-0503
2021-0605
2021-0802
2021-0902.67
2021-1002
2021-1133
2021-1202
2022-0101
2022-0202
2022-0303
2022-0402.67
2022-0502
2022-0602.33
2022-0702
2022-0803.29
2022-0902.11
2022-1001.6
2022-1102.5
2022-1202.25
2023-0102
2023-0202
2023-0302.67
2023-0402
2023-0501.5
2023-0601.67
2023-0701.75
2023-0801
2023-0901
2023-1002
2023-1101.71
2023-1202
2024-0101
2024-0201.5
2024-0301
2024-0401
2024-0501
2024-0601.25
2024-0702
2024-0802
2024-0901.33
2024-1002
2024-1102
2024-1202
2025-0102.5
2025-0202.43
2025-0301.8
2025-0401.5
2025-0502
2025-0602
2025-0702
2025-0802
2025-0903.4
2025-1001.4
2025-1102.67
2025-1202.2
2026-0102.33
2026-0202.25
2026-0302.5
2026-0402.17
2026-0502.86
2026-0602
This device (reports/month)Average device in FLE (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2021-11-109610612-2021-00720MalfunctionAvailablecatalog number

Showing the most recent 1 of 3 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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