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L-Cath™ S/L PICC S/L
Model 26GA (1.9F) x 30cm · ARGON MEDICAL DEVICES, INC. · DI 00886333209934
FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days · Class II · 21 CFR 880.5200
LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days · Class II · 21 CFR 880.5970
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2024-06-14
Z-2638-2024
Class II
Open, Classified
Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
code info di
Adverse-event reports — MAUDE (489)
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: 445 · Injury: 41 · : 3
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
3.3
2019-02
0
3.05
2019-03
0
2.93
2019-04
0
3.33
2019-05
1
3.01
2019-06
1
2.94
2019-07
0
3.3
2019-08
0
3.5
2019-09
1
2.93
2019-10
6
3.38
2019-11
1
2.95
2019-12
2
2.75
2020-01
5
3.64
2020-02
5
3.06
2020-03
6
3
2020-04
1
3.42
2020-05
0
3.2
2020-06
15
3.96
2020-07
30
4.38
2020-08
6
3.59
2020-09
4
3.8
2020-10
0
2.54
2020-11
0
2.26
2020-12
3
2.24
2021-01
6
2.67
2021-02
3
2.5
2021-03
54
2.92
2021-04
15
2.59
2021-05
0
2.19
2021-06
2
2.52
2021-07
0
3.03
2021-08
1
2.74
2021-09
3
2.93
2021-10
8
2.93
2021-11
10
3.19
2021-12
0
2.89
2022-01
9
2.66
2022-02
6
2.49
2022-03
6
2.54
2022-04
2
2.79
2022-05
13
2.57
2022-06
4
2.79
2022-07
2
3.21
2022-08
2
2.44
2022-09
20
2.54
2022-10
4
1.98
2022-11
16
2.72
2022-12
20
2.84
2023-01
24
2.95
2023-02
15
2.67
2023-03
4
2.76
2023-04
10
2.38
2023-05
10
2.66
2023-06
8
2.84
2023-07
0
2.56
2023-08
3
2.97
2023-09
2
2.71
2023-10
2
2.57
2023-11
0
2.58
2023-12
1
2.5
2024-01
2
2.21
2024-02
4
2.45
2024-03
5
2.42
2024-04
10
2.69
2024-05
6
2.6
2024-06
3
2.99
2024-07
2
2.42
2024-08
4
2.65
2024-09
4
2.31
2024-10
1
2.74
2024-11
18
3.13
2024-12
0
2.46
2025-01
1
2.74
2025-02
2
3.06
2025-03
0
3.24
2025-04
2
2.45
2025-05
0
2.96
2025-06
5
2.64
2025-07
1
2.69
2025-08
1
2.48
2025-09
0
2.61
2025-10
4
2.55
2025-11
27
3.39
2025-12
5
2.63
2026-01
1
3.13
2026-02
2
2.68
2026-03
1
2.6
2026-04
0
3.16
2026-05
1
2.43
2026-06
4
3.04
This device (reports/month)Average device in FOZ, LJS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ARGON MEDICAL DEVICES, INC.
Warning Letter 2014-07-03 Argon Medical Devices, Inc
Warning Letter 2014-07-03 Argon Medical Devices, Inc
NAI 2021-11-04 Argon Medical Devices, Inc · 0 citations
NAI 2021-11-04 Argon Medical Devices, Inc · 0 citations
VAI 2016-05-27 Argon Medical Devices, Inc · 2 citations
VAI 2016-05-27 Argon Medical Devices, Inc · 2 citations
NAI 2016-05-04 Argon Medical Devices Inc. · 0 citations
NAI 2016-05-04 Argon Medical Devices Inc. · 0 citations
VAI 2013-12-13 Argon Medical Devices, Inc · 3 citations
VAI 2013-12-13 Argon Medical Devices, Inc · 3 citations
VAI 2012-01-18 Argon Medical Devices Inc. · 3 citations
VAI 2012-01-18 Argon Medical Devices Inc. · 3 citations
VAI 2011-05-18 Argon Medical Devices, Inc · 1 citations
VAI 2011-05-18 Argon Medical Devices, Inc · 1 citations