Millennium · 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 reportsMalfunction 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	3.47
2019-02	0	3.86
2019-03	0	2.58
2019-04	0	2.41
2019-05	0	2.64
2019-06	0	2.8
2019-07	0	2.3
2019-08	0	2.82
2019-09	0	3.22
2019-10	0	3.71
2019-11	0	4.55
2019-12	0	4.16
2020-01	0	4.68
2020-02	0	4.03
2020-03	0	4.19
2020-04	0	3.19
2020-05	0	3
2020-06	0	4.08
2020-07	0	5.14
2020-08	0	5.73
2020-09	0	4.59
2020-10	0	4.66
2020-11	0	4.89
2020-12	0	5.09
2021-01	0	5.21
2021-02	0	3.53
2021-03	0	4.11
2021-04	0	3.96
2021-05	0	5
2021-06	0	5
2021-07	0	3.89
2021-08	0	4.29
2021-09	0	5.44
2021-10	0	4
2021-11	0	4.57
2021-12	0	4.27
2022-01	0	4.78
2022-02	0	5.09
2022-03	0	4.49
2022-04	0	4.85
2022-05	0	3.57
2022-06	0	4.53
2022-07	0	2.83
2022-08	0	4.69
2022-09	0	3.98
2022-10	0	4.17
2022-11	0	4.34
2022-12	0	5.85
2023-01	0	4.46
2023-02	0	4.28
2023-03	0	6.93
2023-04	0	5.88
2023-05	0	5.33
2023-06	0	5.07
2023-07	0	4.25
2023-08	0	3.35
2023-09	0	2.79
2023-10	1	3.59
2023-11	2	3.05
2023-12	0	2.69
2024-01	0	2.35
2024-02	0	3.27
2024-03	0	2.5
2024-04	0	4.28
2024-05	0	3.05
2024-06	0	2.75
2024-07	0	2.56
2024-08	0	3.13
2024-09	0	2.57
2024-10	0	3.41
2024-11	0	3.69
2024-12	0	2.59
2025-01	0	4.12
2025-02	0	2.43
2025-03	0	3.12
2025-04	0	3.12
2025-05	0	4.59
2025-06	0	3.47
2025-07	0	3.32
2025-08	0	3.84
2025-09	0	2.91
2025-10	0	3.13
2025-11	0	4
2025-12	0	3.79
2026-01	0	3.38
2026-02	0	2.4
2026-03	0	3.9
2026-04	0	4.21
2026-05	0	3.76
2026-06	0	3.77

This device (reports/month)Average device in HTW (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
2023-11-15	3008864603-2023-00001	Malfunction	Available	exact di
2023-10-03	17860496	Malfunction	Available	model number

Showing the most recent 2 of 3 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-12-05	VAI	Voluntary action indicated	Instrumed International Inc	5
2022-06-28	VAI	Voluntary action indicated	Avalign Integrated Medical Solutions, Inc.	3
2019-11-20	VAI	Voluntary action indicated	Instrumed International Inc	2
2018-10-25	NAI	No action indicated	Instrumed GmbH	0
2016-11-30	NAI	No action indicated	Instrumed International Inc	0
2015-09-22	NAI	No action indicated	Millennium Surgical Corp	0
2015-01-29	NAI	No action indicated	Instrumed GmbH	0
2014-03-28	WL	Warning Letter	Instrumed GmbH	—
2013-08-20	VAI	Voluntary action indicated	Instrumed International Inc	17
2013-08-01	OAI	Official action indicated	Instrumed GmbH	0
2013-04-24	VAI	Voluntary action indicated	Avalign Integrated Medical Solutions, Inc.	4
2011-02-28	NAI	No action indicated	Instrumed International Inc	0

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