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"ENROUTE 0.014"" Guidewire"
Model 901047-01 · BRIVANT LIMITED · DI 00816349014857
DQX — Wire, Guide, Catheter · Class II · 21 CFR 870.1330
UDILibrary device dossier · generated 2026-09-06 · 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 (59)
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.
Malfunction: 58 · Injury: 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
1.64
2019-02
0
1.52
2019-03
0
1.78
2019-04
0
1.69
2019-05
0
1.69
2019-06
0
1.57
2019-07
0
2.02
2019-08
0
2.38
2019-09
0
2.08
2019-10
0
2.24
2019-11
0
2.03
2019-12
0
2.52
2020-01
0
2.3
2020-02
0
2.95
2020-03
0
2.85
2020-04
0
2.16
2020-05
0
2.68
2020-06
0
2.49
2020-07
0
2.84
2020-08
0
2.54
2020-09
0
2.44
2020-10
0
2.65
2020-11
0
2.68
2020-12
0
2.75
2021-01
0
3.03
2021-02
0
2.16
2021-03
0
2.69
2021-04
0
2.62
2021-05
0
2.05
2021-06
0
2.42
2021-07
0
3.07
2021-08
0
2.39
2021-09
0
2.41
2021-10
0
2.02
2021-11
0
2.34
2021-12
0
2.64
2022-01
0
2.63
2022-02
0
2.35
2022-03
2
2.36
2022-04
2
2.61
2022-05
10
2.86
2022-06
13
2.75
2022-07
8
2.57
2022-08
10
3.01
2022-09
4
2.56
2022-10
0
2.26
2022-11
0
2.62
2022-12
0
2.42
2023-01
0
1.86
2023-02
0
2.64
2023-03
0
2.56
2023-04
0
2.25
2023-05
0
2.99
2023-06
0
2.39
2023-07
0
2.63
2023-08
0
2.65
2023-09
0
2.76
2023-10
0
2.54
2023-11
0
2.64
2023-12
0
2.8
2024-01
0
2.65
2024-02
0
2.63
2024-03
0
2.81
2024-04
0
2.26
2024-05
0
3.29
2024-06
0
3.05
2024-07
0
2.31
2024-08
0
3.62
2024-09
0
3.04
2024-10
0
4.01
2024-11
0
3.37
2024-12
0
3.81
2025-01
0
2.98
2025-02
0
3.19
2025-03
0
3.22
2025-04
0
3.49
2025-05
0
3.33
2025-06
0
2.89
2025-07
1
3.12
2025-08
0
3.21
2025-09
1
3.5
2025-10
1
3.24
2025-11
2
3.94
2025-12
0
4.49
2026-01
3
3.58
2026-02
1
3.79
2026-03
1
3.9
2026-04
0
2.99
2026-05
0
2.69
2026-06
0
2.84
This device (reports/month)Average device in DQX (reports/device/month)