ACTIS · 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.

49 linked reportsMalfunction 49

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	2.16
2019-02	0	1.22
2019-03	0	1.65
2019-04	0	2
2019-05	0	1.94
2019-06	0	1.5
2019-07	0	1.83
2019-08	0	1.5
2019-09	3	2.24
2019-10	3	4.32
2019-11	1	2.15
2019-12	0	2.25
2020-01	0	2
2020-02	0	1.89
2020-03	0	2.33
2020-04	0	2.29
2020-05	0	1.46
2020-06	1	2
2020-07	0	1.81
2020-08	1	2.33
2020-09	0	1.73
2020-10	0	1.91
2020-11	0	1.57
2020-12	0	2.19
2021-01	0	1.53
2021-02	0	1.64
2021-03	0	1.83
2021-04	4	3.46
2021-05	0	1.43
2021-06	0	1.5
2021-07	0	1.56
2021-08	4	3.23
2021-09	0	2.06
2021-10	0	1.85
2021-11	0	1.86
2021-12	0	1.7
2022-01	0	1.87
2022-02	0	2.23
2022-03	0	2.46
2022-04	0	1.56
2022-05	0	2
2022-06	0	1.88
2022-07	3	3.71
2022-08	0	1.87
2022-09	0	1.7
2022-10	0	2
2022-11	0	2.14
2022-12	2	2.86
2023-01	0	2.81
2023-02	1	2.07
2023-03	1	1.62
2023-04	0	2.11
2023-05	1	1.48
2023-06	0	1.82
2023-07	0	2.13
2023-08	0	2.54
2023-09	0	1.92
2023-10	3	3.36
2023-11	0	2.05
2023-12	0	2.09
2024-01	0	2.33
2024-02	0	3.43
2024-03	0	1.69
2024-04	0	1.82
2024-05	0	1.7
2024-06	0	2.67
2024-07	0	1.33
2024-08	0	1.41
2024-09	0	1.5
2024-10	1	1.97
2024-11	0	2.17
2024-12	0	1.62
2025-01	2	1.82
2025-02	0	1.22
2025-03	0	1.42
2025-04	0	1.47
2025-05	4	3.38
2025-06	0	2.21
2025-07	0	2.23
2025-08	0	1.54
2025-09	0	1
2025-10	0	2.07
2025-11	0	1
2025-12	0	1.4
2026-01	0	3.64
2026-02	0	1.22
2026-03	14	9.44
2026-04	0	1.36
2026-05	0	1.8
2026-06	0	1.36

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-03-31	1818910-2026-05510	Malfunction	Available	exact di
2026-03-31	1818910-2026-05511	Malfunction	Available	exact di
2026-03-31	1818910-2026-05509	Malfunction	Available	exact di
2026-03-24	1818910-2026-05183	Malfunction	Available	exact di
2026-03-24	1818910-2026-05179	Malfunction	Available	exact di
2026-03-24	1818910-2026-05184	Malfunction	Available	exact di
2026-03-13	1818910-2026-04756	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04753	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04754	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04755	Malfunction	Available	catalog number
2025-05-30	1818910-2025-08757	Malfunction	Available	catalog number
2025-05-30	1818910-2025-08758	Malfunction	Available	catalog number
2025-01-02	1818910-2025-00032	Malfunction	Available	catalog number
2024-10-21	1818910-2024-21876	Malfunction	Available	exact di
2023-10-12	1818910-2023-20724	Malfunction	Available	exact di

Showing the most recent 42 of 49 linked reports.

Showing 1–15 of 42

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-07-04	NAI	No action indicated	DEPUY (IRELAND)	0
2015-01-08	NAI	No action indicated	DEPUY (IRELAND)	0
2012-01-26	VAI	Voluntary action indicated	DEPUY (IRELAND)	1
2011-02-03	NAI	No action indicated	DEPUY (IRELAND)	0

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