Atlas Wire · 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.

14 linked reportsMalfunction 14

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	2.85
2019-02	0	4.5
2019-03	0	6.08
2019-04	0	4
2019-05	0	5
2019-06	0	6.45
2019-07	4	5.75
2019-08	0	4.64
2019-09	0	5.7
2019-10	0	5.54
2019-11	0	5.42
2019-12	0	4.56
2020-01	0	3.55
2020-02	0	2.44
2020-03	0	2.8
2020-04	0	2.9
2020-05	0	2
2020-06	0	2.4
2020-07	0	2.6
2020-08	0	2.21
2020-09	3	2.67
2020-10	3	4.27
2020-11	0	3
2020-12	0	3.27
2021-01	0	2.27
2021-02	0	2.33
2021-03	0	2
2021-04	0	2.57
2021-05	0	2.38
2021-06	0	2.92
2021-07	0	2.67
2021-08	0	2.42
2021-09	0	2.35
2021-10	0	2.4
2021-11	0	2.83
2021-12	0	2.2
2022-01	0	2.6
2022-02	0	3.22
2022-03	0	2.47
2022-04	0	2.78
2022-05	0	1.92
2022-06	0	2.43
2022-07	0	6
2022-08	0	4.24
2022-09	0	2.73
2022-10	0	3.1
2022-11	0	2.86
2022-12	0	2.33
2023-01	0	2
2023-02	0	2.5
2023-03	0	3.08
2023-04	0	3.73
2023-05	0	3.18
2023-06	0	5.33
2023-07	0	2.85
2023-08	0	4.63
2023-09	0	2.47
2023-10	2	4.08
2023-11	0	3.38
2023-12	0	3.3
2024-01	0	3.28
2024-02	0	4.42
2024-03	0	6.36
2024-04	0	7.43
2024-05	0	7.83
2024-06	0	4.88
2024-07	0	6.81
2024-08	0	6.82
2024-09	0	5.56
2024-10	0	4.4
2024-11	0	5.32
2024-12	0	6.69
2025-01	0	3.81
2025-02	0	3.67
2025-03	0	6.5
2025-04	0	5.37
2025-05	0	6
2025-06	0	7.53
2025-07	0	6.11
2025-08	2	6.37
2025-09	0	6
2025-10	0	7.27
2025-11	0	8.92
2025-12	0	7.24
2026-01	0	5.67
2026-02	0	7.72
2026-03	0	9
2026-04	0	7.36
2026-05	0	7.57
2026-06	0	7.56

This device (reports/month)Average device in FFL (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-08-07	1820334-2025-00953	Malfunction	Available	catalog number
2023-10-12	1820334-2023-01382	Malfunction	Available	catalog number
2020-10-22	1820334-2020-01921	Malfunction	Available	catalog number
2020-09-29	1820334-2020-01771	Malfunction	Available	catalog number
2019-07-03	1820334-2019-01609	Malfunction	Available	catalog number
2019-07-03	1820334-2019-01611	Malfunction	Available	catalog number

Showing the most recent 6 of 14 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-06-04	VAI	Voluntary action indicated	Cook Incorporated	6
2025-06-04	VAI	Voluntary action indicated	Cook Incorporated	6
2024-05-08	VAI	Voluntary action indicated	Cook Incorporated	1
2024-05-08	VAI	Voluntary action indicated	Cook Incorporated	1
2021-09-14	VAI	Voluntary action indicated	Cook Incorporated	2
2021-09-14	VAI	Voluntary action indicated	Cook Incorporated	2
2020-02-07	VAI	Voluntary action indicated	Cook Incorporated	4
2020-02-07	VAI	Voluntary action indicated	Cook Incorporated	4
2018-06-14	VAI	Voluntary action indicated	Cook Incorporated	1
2018-06-14	VAI	Voluntary action indicated	Cook Incorporated	1
2017-05-26	VAI	Voluntary action indicated	Cook Incorporated	3
2017-05-26	VAI	Voluntary action indicated	Cook Incorporated	3
2017-01-26	VAI	Voluntary action indicated	Cook Incorporated	11
2017-01-26	VAI	Voluntary action indicated	Cook Incorporated	11
2016-06-17	VAI	Voluntary action indicated	Cook Inc	2
2016-06-17	VAI	Voluntary action indicated	Cook Inc	2
2016-03-31	NAI	No action indicated	Cook Inc	0
2016-03-31	NAI	No action indicated	Cook Inc	0
2015-03-13	VAI	Voluntary action indicated	Cook Incorporated	5
2015-03-13	VAI	Voluntary action indicated	Cook Incorporated	5
2014-09-16	WL	Warning Letter	Cook Incorporated	—
2014-09-16	WL	Warning Letter	Cook Incorporated	—

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