ACS® · recalls, adverse events, clearances

Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

European UnionACS® FB4048844KNB15FBITIINSTDL

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.

1 linked reportMalfunction 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	8.04
2019-02	0	10.7
2019-03	0	9
2019-04	0	6.8
2019-05	0	5.96
2019-06	0	6.11
2019-07	0	7.09
2019-08	0	6.59
2019-09	0	5.29
2019-10	0	8.2
2019-11	0	7.87
2019-12	0	7.83
2020-01	0	9.32
2020-02	0	5.8
2020-03	0	7.52
2020-04	0	3.87
2020-05	0	3.5
2020-06	0	5.84
2020-07	0	7.81
2020-08	0	7.86
2020-09	0	5.17
2020-10	0	8.95
2020-11	0	4.21
2020-12	0	8.39
2021-01	0	6.96
2021-02	0	5.95
2021-03	0	7.27
2021-04	0	6.14
2021-05	0	8.33
2021-06	0	7.67
2021-07	0	6.87
2021-08	0	6.42
2021-09	0	8.69
2021-10	0	7.78
2021-11	0	8.14
2021-12	0	6.94
2022-01	0	7.29
2022-02	0	4.93
2022-03	0	6.89
2022-04	0	7.73
2022-05	0	5.97
2022-06	0	6.34
2022-07	0	7.3
2022-08	0	6.86
2022-09	0	5.8
2022-10	0	6.3
2022-11	0	7.67
2022-12	0	9
2023-01	0	9.32
2023-02	0	7.11
2023-03	0	7.28
2023-04	0	6.58
2023-05	0	6.32
2023-06	0	5.81
2023-07	0	7.59
2023-08	0	5.71
2023-09	0	4.29
2023-10	0	6.9
2023-11	0	6.06
2023-12	0	4.94
2024-01	0	6.59
2024-02	0	7.17
2024-03	0	4.73
2024-04	0	5.58
2024-05	0	5.3
2024-06	0	5
2024-07	0	4.68
2024-08	0	5.25
2024-09	0	5.16
2024-10	0	6.49
2024-11	0	5.26
2024-12	0	5.42
2025-01	0	6.08
2025-02	0	4.36
2025-03	1	4.71
2025-04	0	4.73
2025-05	0	5.52
2025-06	0	5.73
2025-07	0	6.5
2025-08	0	5.55
2025-09	0	4.73
2025-10	0	4.49
2025-11	0	5.7
2025-12	0	6.43
2026-01	0	5.54
2026-02	0	5.05
2026-03	0	5.37
2026-04	0	6.24
2026-05	0	5.06
2026-06	0	5.5

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

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-03-06	3012523063-2025-00026	Malfunction	Available	model number

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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