ClosureFast Micro Introducer Sheath · 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.

66 linked reportsMalfunction 41Injury 25

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
2019-02	0	1
2019-03	0	2.4
2019-04	0	2
2019-05	0	1.78
2019-06	0	1.5
2019-07	0	1.5
2019-08	0	1.45
2019-09	0	3
2019-10	1	1.33
2019-11	0	3.88
2019-12	1	1.33
2020-01	0	1.67
2020-02	2	1.86
2020-03	1	1.5
2020-04	2	1.75
2020-05	0	1.83
2020-06	2	4.75
2020-07	4	2.25
2020-08	0	1.33
2020-09	0	1.8
2020-10	0	1.6
2020-11	0	1.3
2020-12	0	1.8
2021-01	0	1.75
2021-02	0	1.5
2021-03	0	1.5
2021-04	0	2.17
2021-05	0	1.5
2021-06	0	3
2021-07	0	2.6
2021-08	0	3.33
2021-09	0	3
2021-10	0	1
2021-11	0	1.4
2021-12	0	1.86
2022-01	0	1.14
2022-02	0	1.45
2022-03	0	2.69
2022-04	0	1
2022-05	1	2.45
2022-06	0	1.67
2022-07	0	1.67
2022-08	0	1.67
2022-09	1	1.91
2022-10	0	1.4
2022-11	0	1.5
2022-12	0	1.78
2023-01	0	1.4
2023-02	0	1.67
2023-03	5	2.62
2023-04	3	1.91
2023-05	6	2.3
2023-06	0	2.55
2023-07	0	3.8
2023-08	1	2.95
2023-09	1	4.67
2023-10	1	2.17
2023-11	0	3.36
2023-12	9	3.32
2024-01	2	2.31
2024-02	0	3.25
2024-03	2	2.45
2024-04	2	2.29
2024-05	3	3.27
2024-06	0	3.14
2024-07	0	1.81
2024-08	0	2.18
2024-09	0	2.57
2024-10	0	2.26
2024-11	0	2.25
2024-12	0	1.86
2025-01	0	2.15
2025-02	0	3.63
2025-03	0	2.71
2025-04	0	1.84
2025-05	0	2.05
2025-06	0	2.7
2025-07	4	3.32
2025-08	0	2.62
2025-09	4	1.85
2025-10	0	3.06
2025-11	2	1.86
2025-12	0	2.14
2026-01	0	2.2
2026-02	0	2.24
2026-03	2	3.11
2026-04	0	2.44
2026-05	2	5.14
2026-06	2	2.31

This device (reports/month)Average device in DRE (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
2026-06-05	0001625425-2026-00972	Injury	Available	exact di
2026-05-08	0001625425-2026-00961	Injury	Available	exact di
2026-03-30	0001625425-2026-00949	Injury	Available	exact di
2025-11-14	0001625425-2025-01130	Injury	Available	exact di
2025-09-16	0001625425-2025-01082	Injury	Available	exact di
2025-09-16	0001625425-2025-01081	Injury	Available	exact di
2025-07-03	0001625425-2025-01052	Malfunction	Available	exact di
2025-07-01	0001625425-2025-01048	Malfunction	Available	exact di
2024-05-14	0001625425-2024-01024	Malfunction	Available	exact di
2024-05-09	0001625425-2024-01019	Injury	Available	model number
2024-04-23	0001625425-2024-00991	Malfunction	Available	exact di
2024-03-19	0001625425-2024-00968	Malfunction	Available	exact di
2024-01-08	0001625425-2024-00919	Injury	Available	exact di
2023-12-11	0001625425-2023-01257	Malfunction	Available	model number
2023-12-11	0001625425-2023-01258	Malfunction	Available	model number

Showing the most recent 50 of 66 linked reports.

Showing 1–15 of 50

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2021-11-04	NAI	No action indicated	Argon Medical Devices, Inc	0
2021-11-04	NAI	No action indicated	Argon Medical Devices, Inc	0
2016-05-27	VAI	Voluntary action indicated	Argon Medical Devices, Inc	2
2016-05-27	VAI	Voluntary action indicated	Argon Medical Devices, Inc	2
2016-05-04	NAI	No action indicated	Argon Medical Devices Inc.	0
2016-05-04	NAI	No action indicated	Argon Medical Devices Inc.	0
2014-07-03	WL	Warning Letter	Argon Medical Devices, Inc	—
2014-07-03	WL	Warning Letter	Argon Medical Devices, Inc	—
2013-12-13	VAI	Voluntary action indicated	Argon Medical Devices, Inc	3
2013-12-13	VAI	Voluntary action indicated	Argon Medical Devices, Inc	3
2012-01-18	VAI	Voluntary action indicated	Argon Medical Devices Inc.	3
2012-01-18	VAI	Voluntary action indicated	Argon Medical Devices Inc.	3
2011-05-18	VAI	Voluntary action indicated	Argon Medical Devices, Inc	1
2011-05-18	VAI	Voluntary action indicated	Argon Medical Devices, Inc	1

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