Print-ready dossier — use your browser's print dialog to save as PDF.
MedSource Catheters
Model MS-864203 · MEDSOURCE INTERNATIONAL LLC · DI 00840155413245
FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days · Class II · 21 CFR 880.5200
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 (1)
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.
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
3.17
2019-02
0
2.75
2019-03
0
3.02
2019-04
0
3.16
2019-05
0
2.59
2019-06
0
2.77
2019-07
0
2.83
2019-08
0
3.3
2019-09
0
2.66
2019-10
0
2.47
2019-11
0
2.53
2019-12
0
2.21
2020-01
0
2.52
2020-02
0
2.49
2020-03
0
2.5
2020-04
0
2.95
2020-05
0
2.22
2020-06
0
3.28
2020-07
0
3.37
2020-08
0
3.08
2020-09
0
3.63
2020-10
0
2.3
2020-11
0
2.23
2020-12
0
2.48
2021-01
0
2.98
2021-02
0
2.58
2021-03
0
2.99
2021-04
0
2.58
2021-05
0
2.13
2021-06
0
2.7
2021-07
0
3.3
2021-08
0
2.8
2021-09
0
2.61
2021-10
0
2.74
2021-11
0
2.5
2021-12
0
2.6
2022-01
0
2.98
2022-02
0
1.97
2022-03
0
1.98
2022-04
0
2.56
2022-05
0
2.41
2022-06
0
2.63
2022-07
0
2.13
2022-08
0
2.16
2022-09
0
2.25
2022-10
0
1.99
2022-11
0
2.69
2022-12
0
2.99
2023-01
0
2.66
2023-02
0
2.71
2023-03
0
3.22
2023-04
0
2.33
2023-05
0
2.53
2023-06
0
3.14
2023-07
0
2.29
2023-08
0
3.08
2023-09
0
2.61
2023-10
0
2.6
2023-11
0
2.92
2023-12
0
2.57
2024-01
0
1.94
2024-02
0
2.42
2024-03
0
2.48
2024-04
0
2.65
2024-05
0
2.55
2024-06
0
3.03
2024-07
0
2.43
2024-08
0
2.76
2024-09
0
2.52
2024-10
0
2.9
2024-11
0
3.39
2024-12
0
2.79
2025-01
0
2.85
2025-02
0
3.81
2025-03
0
3.82
2025-04
0
2.98
2025-05
1
3.48
2025-06
0
3.08
2025-07
0
2.54
2025-08
0
2.48
2025-09
0
2.55
2025-10
0
2.63
2025-11
0
3.96
2025-12
0
2.64
2026-01
0
3.4
2026-02
0
2.63
2026-03
0
2.87
2026-04
0
3.31
2026-05
0
2.41
2026-06
0
3.1
This device (reports/month)Average device in FOZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MEDSOURCE INTERNATIONAL LLC
NAI 2024-01-18 Medsource International LLC · 0 citations
VAI 2017-01-06 Medsource International LLC · 3 citations