HALF DOME · 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.

3 linked reportsMalfunction 3

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	1.54
2019-02	0	1.22
2019-03	0	1.69
2019-04	0	1.46
2019-05	0	1.6
2019-06	0	1.57
2019-07	0	1.65
2019-08	0	1.36
2019-09	0	1.32
2019-10	0	1.83
2019-11	0	1.58
2019-12	0	1.36
2020-01	0	1.67
2020-02	0	1.73
2020-03	0	1.45
2020-04	0	1.43
2020-05	0	1.64
2020-06	0	1.84
2020-07	0	1.85
2020-08	0	1.63
2020-09	0	2.52
2020-10	0	2.05
2020-11	0	2.1
2020-12	0	1.76
2021-01	0	1.7
2021-02	0	1.72
2021-03	0	2
2021-04	0	1.55
2021-05	0	1.6
2021-06	0	2.23
2021-07	0	1.73
2021-08	0	2.21
2021-09	0	1.72
2021-10	0	2.11
2021-11	0	1.84
2021-12	0	2.54
2022-01	0	3.14
2022-02	0	2.62
2022-03	0	1.78
2022-04	0	1.76
2022-05	0	2.13
2022-06	0	1.79
2022-07	0	2.21
2022-08	0	1.86
2022-09	0	1.78
2022-10	0	1.87
2022-11	0	1.93
2022-12	0	1.7
2023-01	0	2.44
2023-02	0	2.05
2023-03	0	1.71
2023-04	0	1.81
2023-05	0	2.04
2023-06	0	1.75
2023-07	0	2.04
2023-08	0	1.73
2023-09	0	1.97
2023-10	0	1.85
2023-11	0	10.03
2023-12	0	3.95
2024-01	0	1.86
2024-02	0	2.13
2024-03	0	1.9
2024-04	0	1.36
2024-05	0	1.58
2024-06	0	1.79
2024-07	0	1.93
2024-08	0	2.27
2024-09	0	1.9
2024-10	0	2.13
2024-11	0	1.74
2024-12	0	1.69
2025-01	0	1.85
2025-02	0	1.66
2025-03	0	1.66
2025-04	0	1.6
2025-05	0	1.65
2025-06	0	2.02
2025-07	0	1.81
2025-08	0	1.61
2025-09	3	1.59
2025-10	0	1.71
2025-11	0	2.03
2025-12	0	1.85
2026-01	0	1.94
2026-02	0	1.53
2026-03	0	2.76
2026-04	0	1.57
2026-05	0	1.58
2026-06	0	1.6

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-09-18	3015941638-2025-00008	Malfunction	Available	catalog number

Showing the most recent 1 of 3 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-04-23	VAI	Voluntary action indicated	Astura Medical	5
2026-04-23	VAI	Voluntary action indicated	Astura Medical	5

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