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.

70 linked reportsMalfunction 70

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	1	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	4	2.15
2019-12	1	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	3	2.81
2023-02	2	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	1	1.92
2023-10	3	3.36
2023-11	1	2.05
2023-12	0	2.09
2024-01	1	2.33
2024-02	0	3.43
2024-03	0	1.69
2024-04	3	1.82
2024-05	0	1.7
2024-06	0	2.67
2024-07	0	1.33
2024-08	2	1.41
2024-09	0	1.5
2024-10	0	1.97
2024-11	1	2.17
2024-12	1	1.62
2025-01	1	1.82
2025-02	0	1.22
2025-03	0	1.42
2025-04	1	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	2	2.07
2025-11	1	1
2025-12	0	1.4
2026-01	4	3.64
2026-02	0	1.22
2026-03	10	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	1818910-2026-05493	Malfunction	Available	exact di
2026-03-31	1818910-2026-05495	Malfunction	Available	exact di
2026-03-31	1818910-2026-05494	Malfunction	Available	exact di
2026-03-13	1818910-2026-04774	Malfunction	Available	exact di
2026-03-13	1818910-2026-04776	Malfunction	Available	exact di
2026-03-13	1818910-2026-04775	Malfunction	Available	exact di
2026-03-13	1818910-2026-04769	Malfunction	Available	exact di
2026-03-12	1818910-2026-04721	Malfunction	Available	exact di
2026-03-12	1818910-2026-04664	Malfunction	Available	exact di
2026-03-12	1818910-2026-04665	Malfunction	Available	exact di
2026-01-14	1818910-2026-00802	Malfunction	Available	exact di
2026-01-14	1818910-2026-00801	Malfunction	Available	exact di
2026-01-14	1818910-2026-00804	Malfunction	Available	exact di
2026-01-14	1818910-2026-00796	Malfunction	Available	exact di
2025-11-18	1818910-2025-20241	Malfunction	Available	exact di

Showing the most recent 68 of 70 linked reports.

Showing 1–15 of 68

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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