Midas Rex · 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.

60 linked reportsMalfunction 58Injury 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	1.69
2019-02	0	3.17
2019-03	0	8.24
2019-04	0	4.93
2019-05	0	3.58
2019-06	0	4.13
2019-07	0	3.46
2019-08	0	4.29
2019-09	0	3.62
2019-10	0	3.65
2019-11	0	4
2019-12	0	4.41
2020-01	0	4.42
2020-02	0	3.64
2020-03	0	4.46
2020-04	1	3.95
2020-05	0	2.68
2020-06	0	5.32
2020-07	0	5
2020-08	0	3.79
2020-09	0	4.43
2020-10	0	4.07
2020-11	0	3.86
2020-12	0	5.38
2021-01	0	3.38
2021-02	0	4.09
2021-03	0	5.17
2021-04	0	3.69
2021-05	0	4.2
2021-06	0	5.35
2021-07	0	4.37
2021-08	1	4.07
2021-09	0	3.4
2021-10	0	2.62
2021-11	0	4.2
2021-12	0	3.1
2022-01	0	3.23
2022-02	1	3.12
2022-03	0	3.19
2022-04	0	3.41
2022-05	1	2.68
2022-06	0	4.21
2022-07	0	3
2022-08	0	4.21
2022-09	0	3.56
2022-10	0	3.26
2022-11	0	4.74
2022-12	0	4.26
2023-01	1	3.58
2023-02	0	3.65
2023-03	0	3.45
2023-04	0	4.71
2023-05	0	4.52
2023-06	0	3.91
2023-07	0	5.19
2023-08	0	3.08
2023-09	0	4.05
2023-10	0	3.11
2023-11	0	3.2
2023-12	0	3.5
2024-01	0	3.95
2024-02	0	4.11
2024-03	0	3.56
2024-04	0	4
2024-05	0	2.63
2024-06	0	3.5
2024-07	0	3.28
2024-08	0	3.17
2024-09	0	5.39
2024-10	1	3.38
2024-11	2	3.32
2024-12	0	4.15
2025-01	0	4
2025-02	22	7.82
2025-03	25	9.65
2025-04	4	2.83
2025-05	1	3.21
2025-06	0	3
2025-07	0	4.3
2025-08	0	3.48
2025-09	0	3.33
2025-10	0	4.67
2025-11	0	2.91
2025-12	0	2.64
2026-01	0	2.6
2026-02	0	2.94
2026-03	0	3.8
2026-04	0	3.86
2026-05	0	3
2026-06	0	1.85

This device (reports/month)Average device in HBC (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
2025-05-19	1625507-2025-01600	Malfunction	Available	exact di
2025-04-22	1625507-2025-01486	Malfunction	Available	exact di
2025-04-03	1625507-2025-01221	Malfunction	Available	exact di
2025-04-02	1625507-2025-01201	Malfunction	Available	exact di
2025-04-02	1625507-2025-01207	Malfunction	Available	exact di
2025-03-26	1625507-2025-01089	Malfunction	Available	exact di
2025-03-26	1625507-2025-01079	Malfunction	Available	exact di
2025-03-25	1625507-2025-01045	Malfunction	Available	exact di
2025-03-25	1625507-2025-01054	Malfunction	Available	exact di
2025-03-20	1625507-2025-00958	Malfunction	Available	exact di
2025-03-18	1625507-2025-00919	Malfunction	Available	exact di
2025-03-13	1625507-2025-00822	Malfunction	Available	exact di
2025-03-13	1625507-2025-00828	Malfunction	Available	exact di
2025-03-13	1625507-2025-00818	Malfunction	Available	exact di
2025-03-13	1625507-2025-00813	Malfunction	Available	exact di

Showing 1–15 of 60

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-12-05	NAI	No action indicated	Medtronic Powered Surgical Solutions	0

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