OLYMPIC · 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 reportsInjury 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	2.15
2019-02	0	1.93
2019-03	0	2.11
2019-04	0	2.03
2019-05	0	2.39
2019-06	0	2.66
2019-07	0	1.73
2019-08	0	2.95
2019-09	0	1.79
2019-10	0	1.95
2019-11	0	2.37
2019-12	0	1.72
2020-01	0	2.35
2020-02	0	2.23
2020-03	0	2.08
2020-04	0	1.76
2020-05	0	2.39
2020-06	0	1.85
2020-07	0	1.84
2020-08	0	1.95
2020-09	0	2.53
2020-10	0	2.7
2020-11	0	2.48
2020-12	0	2.15
2021-01	0	2.37
2021-02	0	1.89
2021-03	0	2.55
2021-04	0	2.3
2021-05	0	2.04
2021-06	0	1.73
2021-07	0	7.09
2021-08	0	1.99
2021-09	0	1.72
2021-10	0	2.77
2021-11	0	2.38
2021-12	0	2.38
2022-01	0	2.2
2022-02	0	1.91
2022-03	0	1.88
2022-04	0	2.06
2022-05	0	1.78
2022-06	0	2.07
2022-07	0	4.24
2022-08	0	1.97
2022-09	0	2.99
2022-10	0	1.4
2022-11	0	1.9
2022-12	0	2.03
2023-01	0	1.57
2023-02	0	1.78
2023-03	0	1.82
2023-04	0	1.97
2023-05	0	1.61
2023-06	0	1.79
2023-07	0	1.95
2023-08	0	1.44
2023-09	0	3
2023-10	0	3.04
2023-11	0	3.01
2023-12	0	1.72
2024-01	0	2.61
2024-02	0	2.19
2024-03	3	4.15
2024-04	0	1.83
2024-05	0	3.58
2024-06	0	1.66
2024-07	0	2
2024-08	0	2.1
2024-09	0	2.05
2024-10	0	1.84
2024-11	0	2.27
2024-12	0	1.74
2025-01	0	2.15
2025-02	0	2.52
2025-03	0	2.54
2025-04	0	2.52
2025-05	0	1.81
2025-06	0	1.88
2025-07	0	2.2
2025-08	0	1.82
2025-09	0	2.02
2025-10	0	2.16
2025-11	0	1.99
2025-12	0	2.24
2026-01	0	2.62
2026-02	0	2.52
2026-03	0	2.76
2026-04	0	1.8
2026-05	0	1.65
2026-06	0	5.41

This device (reports/month)Average device in MNH, MNI, OSH (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
2024-03-06	3015941638-2024-00004	Injury	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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