Captura · 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.

2 linked reportsMalfunction 2

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	1	1
2019-03	0	1
2019-04	0	1
2019-05	0	1
2019-06	0	1
2019-07	0	1.67
2019-08	0	1
2019-09	0	1
2019-10	1	1.8
2019-11	0	1
2019-12	0	1
2020-01	0	1
2020-02	0	1.5
2020-03	0	2
2020-04	0	4
2020-05	0	1
2020-07	0	1.33
2020-09	0	1.8
2020-12	0	1
2021-03	0	1
2021-04	0	2
2021-05	0	2
2021-06	0	2
2021-07	0	1
2021-08	0	1
2021-10	0	1.5
2021-12	0	1
2022-03	0	2
2022-04	0	2
2022-05	0	3
2022-07	0	1
2022-08	0	1
2022-09	0	1
2022-10	0	2
2022-12	0	2.5
2023-01	0	1.5
2023-03	0	1
2023-04	0	1.67
2023-05	0	1
2023-06	0	1
2023-07	0	1
2023-09	0	6
2023-10	0	2
2023-11	0	1.5
2023-12	0	1.6
2024-01	0	2
2024-02	0	2
2024-03	0	2
2024-04	0	1.25
2024-05	0	1
2024-06	0	1
2024-07	0	1.2
2024-08	0	1.33
2024-09	0	1.75
2024-10	0	1.8
2024-11	0	1.6
2024-12	0	2
2025-01	0	1.5
2025-02	0	2
2025-03	0	2.8
2025-04	0	1
2025-05	0	1
2025-06	0	1
2025-09	0	1.33
2025-11	0	2.8
2025-12	0	2.2
2026-01	0	3.67
2026-04	0	9.33
2026-05	0	2.25
2026-06	0	2.33

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2019-10-25	1037905-2019-00650	Malfunction	Available	exact di
2019-02-15	1037905-2019-00067	Malfunction	Available	exact di

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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