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.

4 linked reportsInjury 2Malfunction 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	1.14
2019-02	0	1.33
2019-03	2	1.14
2019-04	0	1
2019-05	0	1.67
2019-06	0	1.33
2019-07	0	2.4
2019-08	0	2
2019-09	0	1.2
2019-10	0	1.4
2019-11	0	1
2019-12	0	1
2020-01	0	1.2
2020-02	0	1.75
2020-03	0	2
2020-04	0	1.33
2020-05	0	1
2020-06	0	1.5
2020-07	0	1.4
2020-08	0	2.4
2020-09	0	2
2020-10	0	2
2020-11	0	2.33
2020-12	0	1.67
2021-01	0	1
2021-02	0	1.67
2021-03	0	3
2021-04	0	3.5
2021-06	0	3.25
2021-07	0	2
2021-08	0	2
2021-09	0	2
2021-10	0	2
2021-11	0	1
2021-12	0	1.67
2022-01	0	2.33
2022-02	0	1.67
2022-03	0	1
2022-04	0	1.5
2022-05	0	1.33
2022-06	0	1
2022-07	0	3
2022-08	0	1.8
2022-09	0	3.33
2022-10	0	2.4
2022-11	0	2
2022-12	0	2
2023-01	0	2
2023-03	0	2
2023-04	0	3
2023-05	0	1
2023-06	0	2.33
2023-07	0	3
2023-09	0	1
2023-10	0	1
2023-11	0	1.33
2023-12	0	1
2024-01	0	2.5
2024-02	0	2
2024-03	0	1.75
2024-04	0	1
2024-05	0	2.67
2024-06	0	2
2024-07	0	1
2024-08	0	2
2024-09	0	1.25
2024-10	0	1
2024-11	0	2
2024-12	0	2
2025-02	0	2.67
2025-03	0	2.67
2025-04	0	1
2025-05	0	3
2025-07	0	2.25
2025-08	0	2.25
2025-09	0	2.4
2025-10	0	3
2026-02	0	3
2026-03	0	1.5
2026-04	2	2.5
2026-05	0	3
2026-06	0	2

This device (reports/month)Average device in GXN (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

Date	Report #	Type	Narrative	Link basis
2026-04-24	9610612-2026-00099	Injury	Available	catalog number
2019-03-05	9610612-2019-00161	Malfunction	Available	catalog number

Showing the most recent 2 of 4 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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