Acusnare · 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.

11 linked reportsMalfunction 10Injury 1

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	3.37
2019-02	0	4.38
2019-03	0	4.15
2019-04	0	4.29
2019-05	0	3.84
2019-06	0	3.72
2019-07	0	4.41
2019-08	0	3.59
2019-09	0	4.32
2019-10	0	4.39
2019-11	0	3.67
2019-12	0	3.62
2020-01	0	2.86
2020-02	0	3.79
2020-03	0	3.74
2020-04	0	3.24
2020-05	0	2.57
2020-06	0	3.29
2020-07	0	5.71
2020-08	0	3.2
2020-09	0	4.62
2020-10	0	3.92
2020-11	0	3.26
2020-12	0	4.62
2021-01	0	2.95
2021-02	0	3.77
2021-03	0	4.07
2021-04	1	3.45
2021-05	0	3.44
2021-06	1	4.59
2021-07	0	4.18
2021-08	0	2.36
2021-09	0	3.25
2021-10	0	3.85
2021-11	0	3.3
2021-12	2	3.93
2022-01	0	3.67
2022-02	0	3.36
2022-03	0	3.33
2022-04	0	4.23
2022-05	0	3.17
2022-06	0	4.79
2022-07	0	2.49
2022-08	0	2.61
2022-09	0	2.91
2022-10	0	3.19
2022-11	0	3.08
2022-12	0	2.51
2023-01	0	2.77
2023-02	1	2.22
2023-03	0	2.52
2023-04	0	2.62
2023-05	0	2.72
2023-06	1	2.82
2023-07	0	2.67
2023-08	0	2.5
2023-09	0	3.04
2023-10	0	3.28
2023-11	0	2.96
2023-12	0	2.85
2024-01	0	3.78
2024-02	0	4.16
2024-03	0	3.61
2024-04	0	3.35
2024-05	0	3.53
2024-06	0	2.79
2024-07	0	2.68
2024-08	0	3.96
2024-09	0	3.45
2024-10	0	2.82
2024-11	0	4.42
2024-12	0	5.21
2025-01	0	2.68
2025-02	0	3.31
2025-03	1	2.8
2025-04	0	2.42
2025-05	1	5.34
2025-06	0	3.09
2025-07	0	3.17
2025-08	1	2.9
2025-09	0	4.47
2025-10	0	6.61
2025-11	1	4.13
2025-12	1	3.64
2026-01	0	3.62
2026-02	0	3.21
2026-03	0	4.48
2026-04	0	4.46
2026-05	0	8.03
2026-06	0	3.67

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-12-02	1037905-2025-00808	Malfunction	Available	exact di
2025-11-13	1037905-2025-00770	Malfunction	Available	exact di
2025-08-15	22814581	Malfunction	Available	exact di
2025-05-23	1037905-2025-00406	Malfunction	Available	exact di
2025-03-13	1037905-2025-00204	Malfunction	Available	exact di
2023-06-01	1037905-2023-00266	Malfunction	Available	exact di
2023-02-13	1037905-2023-00063	Injury	Available	exact di
2021-12-07	12951987	Malfunction	Available	catalog number
2021-06-17	1037905-2021-00252	Malfunction	Available	exact di
2021-04-30	1037905-2021-00174	Malfunction	Available	exact di

Showing the most recent 10 of 11 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	—

Similar devices