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	2	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	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	0	1.46
2020-06	1	2
2020-07	2	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	1	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	1	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	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	1	2.54
2023-09	0	1.92
2023-10	4	3.36
2023-11	0	2.05
2023-12	0	2.09
2024-01	1	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	1	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	1	2.21
2025-07	0	2.23
2025-08	0	1.54
2025-09	0	1
2025-10	3	2.07
2025-11	0	1
2025-12	0	1.4
2026-01	4	3.64
2026-02	0	1.22
2026-03	6	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	1818910-2026-05501	Malfunction	Available	exact di
2026-03-31	1818910-2026-05504	Malfunction	Available	exact di
2026-03-31	1818910-2026-05498	Malfunction	Available	exact di
2026-03-13	1818910-2026-04722	Malfunction	Available	exact di
2026-03-12	1818910-2026-04662	Malfunction	Available	exact di
2026-03-12	1818910-2026-04661	Malfunction	Available	exact di
2026-01-13	1818910-2026-00726	Malfunction	Available	exact di
2026-01-13	1818910-2026-00731	Malfunction	Available	exact di
2026-01-13	1818910-2026-00732	Malfunction	Available	exact di
2026-01-13	1818910-2026-00730	Malfunction	Available	exact di
2025-10-15	1818910-2025-17455	Malfunction	Available	exact di
2025-10-15	1818910-2025-17453	Malfunction	Available	exact di
2025-10-15	1818910-2025-17452	Malfunction	Available	exact di
2025-06-23	1818910-2025-10311	Malfunction	Available	exact di
2025-05-30	1818910-2025-08753	Malfunction	Available	catalog number

Showing the most recent 58 of 61 linked reports.

Showing 1–15 of 58

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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