Acessa ProVu System · 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 reportsInjury 6Malfunction 5

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	3.5
2019-02	0	6.03
2019-03	0	6.61
2019-04	0	4.04
2019-05	0	6.29
2019-06	0	6.43
2019-07	0	6
2019-08	0	8.83
2019-09	0	4.33
2019-10	0	3.77
2019-11	0	4.12
2019-12	0	5.4
2020-01	0	2.92
2020-02	0	5.33
2020-03	0	6.39
2020-04	0	5.93
2020-05	0	3.02
2020-06	0	3.29
2020-07	0	4.37
2020-08	0	2.98
2020-09	0	2.09
2020-10	2	3.7
2020-11	0	3.98
2020-12	0	5.64
2021-01	0	6.19
2021-02	0	4.44
2021-03	0	6.82
2021-04	0	4.18
2021-05	0	5.62
2021-06	0	6.19
2021-07	1	7.4
2021-08	0	6.62
2021-09	0	8.31
2021-10	0	5.71
2021-11	1	5.89
2021-12	0	9.23
2022-01	0	6.23
2022-02	0	8.02
2022-03	0	6.71
2022-04	0	7.21
2022-05	0	8.62
2022-06	0	6.86
2022-07	0	6.33
2022-08	0	5.27
2022-09	1	4.33
2022-10	0	4.3
2022-11	1	4.05
2022-12	0	4.88
2023-01	0	4.92
2023-02	0	4.39
2023-03	0	5.31
2023-04	0	3.64
2023-05	1	5.12
2023-06	0	3.81
2023-07	0	3.97
2023-08	0	5.39
2023-09	0	5.29
2023-10	0	6.62
2023-11	0	4.95
2023-12	0	5.02
2024-01	0	6.16
2024-02	0	4.29
2024-03	0	5.51
2024-04	0	5.23
2024-05	0	4.03
2024-06	0	5.58
2024-07	0	4.82
2024-08	0	5.39
2024-09	0	5.39
2024-10	0	6.14
2024-11	1	3.66
2024-12	0	9.9
2025-01	0	4.19
2025-02	0	3.77
2025-03	0	5.25
2025-04	0	3.22
2025-05	0	3.81
2025-06	0	4.04
2025-07	2	4.05
2025-08	0	5.64
2025-09	0	6.86
2025-10	0	9.23
2025-11	0	11.91
2025-12	0	17.74
2026-01	0	11.63
2026-02	1	6.2
2026-03	0	8.47
2026-04	0	11.3
2026-05	0	15.27
2026-06	0	14.23

This device (reports/month)Average device in HFG, ITX, IYO, OEW (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
2026-02-26	1222780-2026-00091	Injury	Available	exact di
2025-07-15	1222780-2025-00383	Malfunction	Available	exact di
2025-07-09	1222780-2025-00371	Malfunction	Available	exact di
2024-11-13	1222780-2024-00426	Malfunction	Available	exact di
2023-05-12	1222780-2023-00167	Malfunction	Available	exact di
2022-11-17	1222780-2022-00357	Malfunction	Available	exact di
2022-09-09	1222780-2022-00244	Injury	Available	exact di
2021-11-12	3006443171-2021-00014	Injury	Available	model number
2021-07-23	3006443171-2021-00001	Injury	Available	procode brand trgm
2020-10-19	3006443171-2020-00003	Injury	Available	exact di

Showing the most recent 10 of 11 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2018-04-18	NAI	No action indicated	Acessa Health Inc.
2014-11-03	NAI	No action indicated	Acessa Health Inc.
2012-02-17	NAI	No action indicated	Acessa Health Inc.

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