iLED · 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.

25 linked reportsInjury 17Malfunction 8

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-02	0	1
2019-03	0	1
2019-04	0	1
2019-05	0	2
2019-07	0	2
2019-08	0	2
2019-09	0	3
2019-11	0	1
2019-12	0	2.5
2020-01	0	3
2020-02	0	3
2020-03	0	1.33
2020-04	0	2
2020-05	0	1
2020-06	0	2
2020-07	0	1.4
2020-08	0	2.67
2020-09	0	1
2020-10	0	1.75
2020-11	0	2
2020-12	0	1
2021-01	0	1
2021-02	0	1.83
2021-03	0	1.88
2021-04	0	1.43
2021-05	0	1.8
2021-06	0	2
2021-08	0	1.25
2021-09	0	1
2021-10	0	2.78
2021-11	0	1
2021-12	0	1.1
2022-01	1	1.22
2022-02	0	1.25
2022-03	0	4.57
2022-04	0	1
2022-05	0	2.67
2022-06	0	1.25
2022-07	0	2.6
2022-08	0	2.33
2022-09	0	1.47
2022-10	0	1.58
2022-11	0	1.4
2022-12	0	1.08
2023-01	0	1.27
2023-02	0	3.17
2023-03	0	2.58
2023-04	0	1.17
2023-05	0	1.22
2023-06	5	2.08
2023-07	0	1.6
2023-08	0	1.88
2023-09	12	6
2023-10	0	1.78
2023-11	2	1.8
2023-12	0	1.64
2024-01	0	1.79
2024-02	0	1.67
2024-03	0	1.64
2024-04	0	3
2024-05	0	1.89
2024-06	2	1.91
2024-07	0	2.73
2024-08	0	2.33
2024-09	0	2.15
2024-10	0	1.74
2024-11	0	1.41
2024-12	1	1.85
2025-01	0	3.39
2025-02	0	1.87
2025-03	0	1.65
2025-04	0	2.17
2025-05	0	1.78
2025-06	0	2.17
2025-07	0	1.88
2025-08	1	1.35
2025-09	0	2.5
2025-10	0	2.14
2025-11	0	1.93
2025-12	0	2.14
2026-01	0	2.6
2026-02	1	1.3
2026-03	0	3.45
2026-04	0	3
2026-05	0	2
2026-06	0	3.08

This device (reports/month)Average device in FQP, FSQ, FSY, FTD (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-02-12	3007143268-2026-00004	Injury	Available	exact di
2025-08-04	3007143268-2025-00062	Malfunction	Available	exact di
2024-12-09	3007143268-2024-00076	Injury	Available	model number
2024-06-18	3007143268-2024-00026	Malfunction	Available	exact di
2023-11-16	3007143268-2023-00045	Malfunction	Available	model number
2023-11-10	3007143268-2023-00044	Malfunction	Available	model number
2023-09-27	3007143268-2023-00042	Injury	Available	exact di
2023-09-27	3007143268-2023-00039	Injury	Available	model number
2023-09-27	3007143268-2023-00041	Injury	Available	exact di
2023-09-27	3007143268-2023-00040	Injury	Available	model number
2023-09-21	3007143268-2023-00036	Injury	Available	exact di
2023-09-21	3007143268-2023-00037	Injury	Available	exact di
2023-09-19	3007143268-2023-00035	Injury	Available	exact di
2023-06-29	3007143268-2023-00025	Malfunction	Available	exact di
2023-06-13	3007143268-2023-00021	Injury	Available	exact di

Showing the most recent 17 of 25 linked reports.

Showing 1–15 of 17

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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