SIRION · 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.

2 linked reportsInjury 2

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	2.12
2019-02	0	1.9
2019-03	0	1.84
2019-04	0	1.84
2019-05	0	1.96
2019-06	0	2.04
2019-07	0	1.75
2019-08	0	2.78
2019-09	0	1.73
2019-10	0	2.06
2019-11	0	2.18
2019-12	0	1.73
2020-01	0	2.71
2020-02	0	2.04
2020-03	0	1.97
2020-04	0	1.68
2020-05	0	2.18
2020-06	0	2.14
2020-07	0	2.04
2020-08	0	1.9
2020-09	0	2.24
2020-10	0	2.51
2020-11	0	2.69
2020-12	0	2.07
2021-01	0	1.76
2021-02	0	1.85
2021-03	0	2.31
2021-04	0	1.96
2021-05	0	1.87
2021-06	0	2.03
2021-07	0	2.25
2021-08	0	2.25
2021-09	0	1.87
2021-10	0	2.7
2021-11	0	2.1
2021-12	0	2.52
2022-01	0	2.3
2022-02	0	2.14
2022-03	0	1.81
2022-04	0	1.75
2022-05	0	1.97
2022-06	0	2.16
2022-07	0	3.4
2022-08	0	2.29
2022-09	0	2.82
2022-10	0	1.62
2022-11	0	2.09
2022-12	0	2.12
2023-01	0	2.03
2023-02	0	2.15
2023-03	0	2.21
2023-04	0	1.78
2023-05	0	1.98
2023-06	0	1.59
2023-07	0	1.94
2023-08	0	1.36
2023-09	2	2.61
2023-10	0	2.39
2023-11	0	2.36
2023-12	0	1.81
2024-01	0	2.36
2024-02	0	2.13
2024-03	0	3.6
2024-04	0	1.66
2024-05	0	3.02
2024-06	0	3.55
2024-07	0	2.16
2024-08	0	1.76
2024-09	0	2.97
2024-10	0	2.23
2024-11	0	1.69
2024-12	0	1.65
2025-01	0	2.26
2025-02	0	2.53
2025-03	0	2.33
2025-04	0	2.2
2025-05	0	2.74
2025-06	0	2.34
2025-07	0	2.03
2025-08	0	2.03
2025-09	0	2.04
2025-10	0	1.93
2025-11	0	1.98
2025-12	0	2.65
2026-01	0	2.69
2026-02	0	2.47
2026-03	0	2.83
2026-04	0	2
2026-05	0	2.46
2026-06	0	4.37

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-09-01	3011764740-2023-00002	Injury	Available	exact di

Showing the most recent 1 of 2 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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