MIDAS REX MR8 · 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.

83 linked reportsMalfunction 82Injury 1

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	2.29
2019-02	0	3.68
2019-03	0	4.9
2019-04	0	3.39
2019-05	0	4
2019-06	0	3.65
2019-07	0	3.23
2019-08	0	3.89
2019-09	0	2.94
2019-10	0	3
2019-11	0	3.32
2019-12	0	3.76
2020-01	0	3.19
2020-02	0	6.36
2020-03	0	5.11
2020-04	0	3.12
2020-05	0	2.9
2020-06	0	4.24
2020-07	0	3.8
2020-08	0	3.06
2020-09	0	4.6
2020-10	0	3.78
2020-11	0	4.29
2020-12	0	4.34
2021-01	0	3.3
2021-02	0	3.03
2021-03	0	3.51
2021-04	0	2.92
2021-05	0	2.73
2021-06	0	3.62
2021-07	0	3.29
2021-08	0	4.9
2021-09	0	3.59
2021-10	0	2.88
2021-11	0	3.54
2021-12	0	4.3
2022-01	0	2.93
2022-02	0	3.79
2022-03	0	3.94
2022-04	0	2.55
2022-05	0	3.36
2022-06	0	3.9
2022-07	0	3.02
2022-08	0	3.9
2022-09	0	4.04
2022-10	0	3.41
2022-11	0	3.62
2022-12	0	4.61
2023-01	0	3.21
2023-02	0	3.83
2023-03	0	3.93
2023-04	0	3.25
2023-05	0	4.68
2023-06	0	4.04
2023-07	0	2.9
2023-08	0	3.5
2023-09	0	3.58
2023-10	0	2.62
2023-11	0	4.11
2023-12	0	2.85
2024-01	0	3.18
2024-02	0	3.13
2024-03	0	3.59
2024-04	0	2.68
2024-05	0	2.7
2024-06	0	3.29
2024-07	0	2.6
2024-08	2	2.75
2024-09	2	3.49
2024-10	0	2.67
2024-11	0	2.16
2024-12	0	3.35
2025-01	0	2.56
2025-02	2	3.52
2025-03	2	2.34
2025-04	0	1.85
2025-05	0	2.19
2025-06	0	2.48
2025-07	1	2.47
2025-08	0	1.85
2025-09	1	2
2025-10	0	2.75
2025-11	0	3.08
2025-12	1	2.91
2026-01	0	2.01
2026-02	0	2.5
2026-03	7	4.3
2026-04	9	4.4
2026-05	10	4.84
2026-06	46	15.24

This device (reports/month)Average device in HBE (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
2026-06-30	1625507-2026-03860	Malfunction	—	exact di
2026-06-29	1625507-2026-03811	Malfunction	—	exact di
2026-06-29	1625507-2026-03800	Malfunction	—	exact di
2026-06-26	1625507-2026-03745	Malfunction	—	exact di
2026-06-26	1625507-2026-03684	Malfunction	—	exact di
2026-06-25	1625507-2026-03593	Malfunction	—	exact di
2026-06-25	1625507-2026-03623	Malfunction	—	exact di
2026-06-22	1625507-2026-03361	Malfunction	Available	exact di
2026-06-21	1625507-2026-03274	Malfunction	Available	exact di
2026-06-21	1625507-2026-03270	Malfunction	Available	exact di
2026-06-19	1625507-2026-03197	Malfunction	Available	exact di
2026-06-19	1625507-2026-03178	Malfunction	Available	exact di
2026-06-19	1625507-2026-03244	Malfunction	Available	exact di
2026-06-19	1625507-2026-03234	Malfunction	Available	exact di
2026-06-18	1625507-2026-03116	Malfunction	Available	exact di

Showing 1–15 of 83

Regulatory clearances

Predicate lineage

K183515

Cited as predicate by: K183644, K202552, K213454, K252662

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

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

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