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Agile Angler
Model ADM18-147 · Agile Devices, Inc. · DI G544ADM18147
KRA — Catheter, Continuous Flush · Class II · 21 CFR 870.1210
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
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
2.53
2019-02
0
1.39
2019-03
0
1.92
2019-04
0
1.58
2019-05
0
1.77
2019-06
0
2.3
2019-07
0
1.7
2019-08
0
1.85
2019-09
0
1.85
2019-10
0
1.83
2019-11
0
1.65
2019-12
0
1.59
2020-01
0
2.25
2020-02
0
2.08
2020-03
0
2.29
2020-04
0
1.89
2020-05
0
2.06
2020-06
0
2.56
2020-07
0
2.13
2020-08
0
2.46
2020-09
0
1.95
2020-10
0
1.96
2020-11
0
1.81
2020-12
0
1.67
2021-01
0
1.71
2021-02
0
2.09
2021-03
0
2.5
2021-04
0
2
2021-05
0
2.21
2021-06
0
1.87
2021-07
0
1.93
2021-08
0
2.42
2021-09
0
2.18
2021-10
0
2.07
2021-11
0
1.65
2021-12
0
1.71
2022-01
0
1.53
2022-02
0
1.92
2022-03
0
2.65
2022-04
0
1.91
2022-05
0
1.46
2022-06
0
2.32
2022-07
0
2.21
2022-08
0
2.17
2022-09
0
1.7
2022-10
0
2.09
2022-11
0
2.37
2022-12
0
1.91
2023-01
0
1.91
2023-02
0
1.76
2023-03
0
2.19
2023-04
0
2.39
2023-05
0
2.35
2023-06
0
2.06
2023-07
0
2.55
2023-08
0
2.62
2023-09
0
1.94
2023-10
0
2.42
2023-11
0
2.08
2023-12
0
2.38
2024-01
0
2.26
2024-02
0
2.23
2024-03
0
1.95
2024-04
0
2.32
2024-05
0
2.09
2024-06
0
2.06
2024-07
0
2.62
2024-08
0
2.15
2024-09
0
2.62
2024-10
0
2.58
2024-11
0
2.67
2024-12
0
2.44
2025-01
0
3.34
2025-02
0
2.13
2025-03
0
2.9
2025-04
0
2.6
2025-05
0
2.71
2025-06
0
3.18
2025-07
0
3.18
2025-08
0
3.24
2025-09
0
2.63
2025-10
0
2.54
2025-11
0
3.33
2025-12
0
2.69
2026-01
0
4.26
2026-02
0
3.21
2026-03
0
3.52
2026-04
0
2.64
2026-05
0
3.04
2026-06
0
3.78
This device (reports/month)Average device in KRA (reports/device/month)