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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.

4 linked reportsMalfunction 4
12452019-01: 0 reports for this device; peer average 1.53/device2019-02: 0 reports for this device; peer average 1.38/device2019-03: 0 reports for this device; peer average 1.55/device2019-04: 0 reports for this device; peer average 1.93/device2019-05: 0 reports for this device; peer average 1.19/device2019-06: 0 reports for this device; peer average 2.08/device2019-07: 4 reports for this device; peer average 4.69/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.46/device2019-10: 0 reports for this device; peer average 1.57/device2019-11: 0 reports for this device; peer average 2.21/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 1.41/device2020-02: 0 reports for this device; peer average 1.9/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.4/device2020-06: 0 reports for this device; peer average 2.09/device2020-07: 0 reports for this device; peer average 1.8/device2020-08: 0 reports for this device; peer average 3.45/device2020-09: 0 reports for this device; peer average 1.74/device2020-10: 0 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 1.29/device2020-12: 0 reports for this device; peer average 2.54/device2021-01: 0 reports for this device; peer average 1.29/device2021-02: 0 reports for this device; peer average 1.81/device2021-03: 0 reports for this device; peer average 1.63/device2021-04: 0 reports for this device; peer average 1.95/device2021-05: 0 reports for this device; peer average 2.07/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.46/device2021-08: 0 reports for this device; peer average 2.06/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2.07/device2021-11: 0 reports for this device; peer average 1.81/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2.79/device2022-02: 0 reports for this device; peer average 2.19/device2022-03: 0 reports for this device; peer average 1.89/device2022-04: 0 reports for this device; peer average 2.05/device2022-05: 0 reports for this device; peer average 2.54/device2022-06: 0 reports for this device; peer average 2.68/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 2.05/device2022-09: 0 reports for this device; peer average 1.79/device2022-10: 0 reports for this device; peer average 2.17/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.75/device2023-01: 0 reports for this device; peer average 1.67/device2023-02: 0 reports for this device; peer average 1.4/device2023-03: 0 reports for this device; peer average 1.96/device2023-04: 0 reports for this device; peer average 1.54/device2023-05: 0 reports for this device; peer average 1.89/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1.37/device2023-08: 0 reports for this device; peer average 1.83/device2023-09: 0 reports for this device; peer average 2.38/device2023-10: 0 reports for this device; peer average 1.44/device2023-11: 0 reports for this device; peer average 2.5/device2023-12: 0 reports for this device; peer average 1.88/device2024-01: 0 reports for this device; peer average 2.1/device2024-02: 0 reports for this device; peer average 2.38/device2024-03: 0 reports for this device; peer average 2.5/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2.95/device2024-06: 0 reports for this device; peer average 1.83/device2024-07: 0 reports for this device; peer average 1.64/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 2.56/device2024-10: 0 reports for this device; peer average 1.58/device2024-11: 0 reports for this device; peer average 1.56/device2024-12: 0 reports for this device; peer average 1.94/device2025-01: 0 reports for this device; peer average 1.49/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1.47/device2025-05: 0 reports for this device; peer average 4.14/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 1.23/device2025-08: 0 reports for this device; peer average 1.93/device2025-09: 0 reports for this device; peer average 1.6/device2025-10: 0 reports for this device; peer average 1.57/device2025-11: 0 reports for this device; peer average 1.77/device2025-12: 0 reports for this device; peer average 2.74/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 1.88/device2026-03: 0 reports for this device; peer average 2.22/device2026-04: 0 reports for this device; peer average 1.83/device2026-05: 0 reports for this device; peer average 2.06/device2026-06: 0 reports for this device; peer average 1.87/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.53
2019-0201.38
2019-0301.55
2019-0401.93
2019-0501.19
2019-0602.08
2019-0744.69
2019-0801.33
2019-0901.46
2019-1001.57
2019-1102.21
2019-1201.67
2020-0101.41
2020-0201.9
2020-0301.45
2020-0401.43
2020-0501.4
2020-0602.09
2020-0701.8
2020-0803.45
2020-0901.74
2020-1002.25
2020-1101.29
2020-1202.54
2021-0101.29
2021-0201.81
2021-0301.63
2021-0401.95
2021-0502.07
2021-0602
2021-0702.46
2021-0802.06
2021-0902
2021-1002.07
2021-1101.81
2021-1202
2022-0102.79
2022-0202.19
2022-0301.89
2022-0402.05
2022-0502.54
2022-0602.68
2022-0702
2022-0802.05
2022-0901.79
2022-1002.17
2022-1102
2022-1201.75
2023-0101.67
2023-0201.4
2023-0301.96
2023-0401.54
2023-0501.89
2023-0601.67
2023-0701.37
2023-0801.83
2023-0902.38
2023-1001.44
2023-1102.5
2023-1201.88
2024-0102.1
2024-0202.38
2024-0302.5
2024-0402
2024-0502.95
2024-0601.83
2024-0701.64
2024-0802
2024-0902.56
2024-1001.58
2024-1101.56
2024-1201.94
2025-0101.49
2025-0202
2025-0301.5
2025-0401.47
2025-0504.14
2025-0603
2025-0701.23
2025-0801.93
2025-0901.6
2025-1001.57
2025-1101.77
2025-1202.74
2026-0101.71
2026-0201.88
2026-0302.22
2026-0401.83
2026-0502.06
2026-0601.87
This device (reports/month)Average device in GFA (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-07-299610612-2019-00486MalfunctionAvailablecatalog number
2019-07-299610612-2019-00485MalfunctionAvailablecatalog number

Showing the most recent 2 of 4 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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