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.

61 linked reportsMalfunction 61

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	1	1.5
2019-07	0	1.83
2019-08	0	1.5
2019-09	3	2.24
2019-10	0	4.32
2019-11	2	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	1	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	2	1.57
2020-12	0	2.19
2021-01	1	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	0	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	0	3.71
2022-08	0	1.87
2022-09	0	1.7
2022-10	0	2
2022-11	0	2.14
2022-12	0	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	3	2.54
2023-09	0	1.92
2023-10	4	3.36
2023-11	0	2.05
2023-12	1	2.09
2024-01	0	2.33
2024-02	0	3.43
2024-03	0	1.69
2024-04	1	1.82
2024-05	0	1.7
2024-06	0	2.67
2024-07	0	1.33
2024-08	1	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	0	1.47
2025-05	2	3.38
2025-06	0	2.21
2025-07	0	2.23
2025-08	0	1.54
2025-09	0	1
2025-10	1	2.07
2025-11	0	1
2025-12	0	1.4
2026-01	4	3.64
2026-02	0	1.22
2026-03	20	9.44
2026-04	0	1.36
2026-05	1	1.8
2026-06	1	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
2026-06-18	1818910-2026-10416	Malfunction	Available	exact di
2026-05-15	1818910-2026-08848	Malfunction	Available	exact di
2026-03-30	1818910-2026-05428	Malfunction	Available	exact di
2026-03-30	1818910-2026-05430	Malfunction	Available	exact di
2026-03-30	1818910-2026-05423	Malfunction	Available	exact di
2026-03-19	1818910-2026-04993	Malfunction	Available	exact di
2026-03-19	1818910-2026-04994	Malfunction	Available	exact di
2026-03-19	1818910-2026-04996	Malfunction	Available	exact di
2026-03-19	1818910-2026-04995	Malfunction	Available	exact di
2026-03-19	1818910-2026-04997	Malfunction	Available	exact di
2026-03-13	1818910-2026-04802	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04798	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04799	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04801	Malfunction	Available	catalog number
2026-03-13	1818910-2026-04797	Malfunction	Available	exact di

Showing the most recent 56 of 61 linked reports.

Showing 1–15 of 56

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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