Argon Medical Devices Inc.
FDA adverse event reports naming Argon Medical Devices Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ARGON MEDICAL DEVICES INC..
- Total reports
- 1,379
- Deaths
- 24
- Injuries
- 734
- Malfunctions
- 612
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Filter, Intravascular, CardiovascularDTK703
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ302
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS92
- Instrument, BiopsyKNW76
- Wire, Guide, CatheterDQX40
- Introducer, CatheterDYB39
- Dilator, Vessel, For Percutaneous CatheterizationDRE20
- Stents, Drains And Dilators For The Biliary DuctsFGE12
- Gauze/Sponge, Internal, X-Ray DetectableGDY11
- Catheter, Continuous FlushKRA9
Recent recalls
- 2026-07-24Open, ClassifiedDevice Design
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
- 2026-07-24Open, ClassifiedDevice Design
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
- 2026-07-10Open, ClassifiedMaterial/Component Contamination
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- 2026-07-10Open, ClassifiedMaterial/Component Contamination
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- 2026-07-10Open, ClassifiedMaterial/Component Contamination
General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- 2026-07-10Open, ClassifiedMaterial/Component Contamination
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- 2026-07-10Open, ClassifiedMaterial/Component Contamination
Arterial Line Kit 20ga x 6, REF: 400115A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- 2026-07-10Open, ClassifiedMaterial/Component Contamination
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- 2025-11-24Open, ClassifiedEquipment maintenance
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
- 2024-09-20Open, ClassifiedPackaging change control
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
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