AESCULAP · recalls, adverse events, clearances

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

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	2.58
2019-02	0	3.33
2019-03	0	3.74
2019-04	0	3.69
2019-05	0	4.41
2019-06	0	4.25
2019-07	0	3.27
2019-08	0	3.76
2019-09	0	4.46
2019-10	0	3.61
2019-11	0	4.11
2019-12	0	5.1
2020-01	0	3.63
2020-02	0	3.58
2020-03	0	5.1
2020-04	0	3.2
2020-05	0	3.36
2020-06	0	4.14
2020-07	0	3.39
2020-08	0	3.43
2020-09	0	4.41
2020-10	2	3.54
2020-11	0	4.43
2020-12	0	3.99
2021-01	0	3.27
2021-02	0	4.16
2021-03	0	4.19
2021-04	0	3.43
2021-05	0	4.14
2021-06	0	3.28
2021-07	0	3.13
2021-08	0	3.23
2021-09	0	2.86
2021-10	0	2.45
2021-11	0	3.12
2021-12	0	3.39
2022-01	0	2.78
2022-02	0	3.19
2022-03	0	3.54
2022-04	0	2.74
2022-05	0	3.21
2022-06	0	4
2022-07	0	2.91
2022-08	0	3.36
2022-09	0	4.56
2022-10	0	3.35
2022-11	0	4.01
2022-12	0	4.75
2023-01	0	2.68
2023-02	0	3.58
2023-03	0	3.39
2023-04	0	2.7
2023-05	0	3.96
2023-06	0	3.82
2023-07	0	3.12
2023-08	0	3.37
2023-09	0	3.45
2023-10	0	2.39
2023-11	0	4.19
2023-12	0	3.29
2024-01	0	2.75
2024-02	0	3.92
2024-03	0	3.19
2024-04	0	2.93
2024-05	0	4.13
2024-06	0	4.3
2024-07	0	2.68
2024-08	0	2.43
2024-09	0	3.43
2024-10	0	2.78
2024-11	0	2.65
2024-12	0	2.76
2025-01	0	2.76
2025-02	0	2.87
2025-03	0	2.57
2025-04	0	1.99
2025-05	0	3.71
2025-06	0	3.22
2025-07	0	2.67
2025-08	0	2.97
2025-09	0	2.45
2025-10	0	2.53
2025-11	0	3.72
2025-12	0	3.34
2026-01	0	2.39
2026-02	0	2.89
2026-03	0	2.79
2026-04	0	3.18
2026-05	0	3.04
2026-06	0	3.16

This device (reports/month)Average device in HBB, HWE (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

Date	Report #	Type	Narrative	Link basis
2020-10-30	9610612-2020-00802	Malfunction	Available	catalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-07-11	NAI	No action indicated	Aesculap Inc	0
2025-07-11	NAI	No action indicated	Aesculap Inc	0
2022-07-21	NAI	No action indicated	Aesculap AG	0
2022-07-21	NAI	No action indicated	Aesculap AG	0
2021-08-11	VAI	Voluntary action indicated	Aesculap Inc	3
2021-08-11	VAI	Voluntary action indicated	Aesculap Inc	3
2018-06-13	VAI	Voluntary action indicated	Aesculap Inc	0
2018-06-13	VAI	Voluntary action indicated	Aesculap Inc	0
2016-09-22	NAI	No action indicated	Aesculap AG	0
2016-09-22	NAI	No action indicated	Aesculap AG	0
2016-09-14	VAI	Voluntary action indicated	Aesculap Inc	0
2016-09-14	VAI	Voluntary action indicated	Aesculap Inc	0
2016-07-13	NAI	No action indicated	Aesculap Inc	0
2016-07-13	NAI	No action indicated	Aesculap Inc	0
2015-07-16	NAI	No action indicated	Aesculap AG	1
2015-07-16	NAI	No action indicated	Aesculap AG	1
2015-05-05	NAI	No action indicated	Aesculap Inc	0
2015-05-05	NAI	No action indicated	Aesculap Inc	0
2014-10-23	NAI	No action indicated	Aesculap Inc	0
2014-10-23	NAI	No action indicated	Aesculap Inc	0
2011-09-26	WL	Warning Letter	Aesculap AG	—
2011-09-26	WL	Warning Letter	Aesculap AG	—

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