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
- 1,378
- Deaths
- 24
- Injuries
- 733
- Malfunctions
- 612
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Filter, Intravascular, CardiovascularDTK702
- 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
- 2026-07-10Open, 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.
- 2024-08-16Open, ClassifiedEmployee error
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
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.
- 2023-07-27Open, ClassifiedUnder Investigation by firm
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
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