Arterial Line KitRecalls & reported problems across all models

We found 2 models of Arterial Line Kit by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2022 and Apr 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Arterial Line Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 1, 2026Open, Classified

   Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

   Z-2708-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported Arterial Line Kit problems

Arterial Line Kit models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Arterial Line Kit 400115A

  Gauze/Sponge, Internal, X-Ray Detectable
  1 recall0 reports
• Arterial Line Kit 498411B

  Gauze/Sponge, Internal, X-Ray Detectable
  2 reports

Recent Arterial Line Kit adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Break; Entrapment of Device; Patient Device Interaction Problem

  THE ARTERIAL LINE WAS PLACED ON THE . THE PATIENTS ARTERIAL LINE DRESSING WAS CHANGED PER HOSPITAL PROTOCOL AFTER REMOVING THE PREVIOUS DRESSING . ANEW DRESSING WAS APPLIED THE ARTERIAL LINE WAS FUNCTIONING PROPERLY FOR A FEW MINUTES AFTER THE DRESSING CHANGE AS THE ARTERIAL LINE TUBING WAS BEING SECURED. THE PATENT BENT HER WRIST AND THE ARTERIAL LINE WAS INADVERTENTLY REMOVED IN THE PROCESS AFTER THE BLEEDING WAS MANAGED. THE DRESSING WAS REMOVED AND IMMEDIATELY IT WAS RECOGNIZED THAT THE MAJORITY OF THE ARTERIAL LINE CATHETER BAD BROKEN OFF AND REMAINED IN THE PATENTS ARTERY. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED PORTION OF THE ARTERIAL CATHETER, THE INCLUDED MANUFACTURING INFO (SERIAL LOT NUMBER) WAS RETRIEVED FROM AN ARTERIAL LINE KIT ON THE DAY OF THE EVENT. UNSURE IF IT IS THE SPECIFIC INFORMATION FOR THE DEVICE RELATED TO THIS REPORT OF NOTE PREVIOUS REPORT WITH A SIMILAR ISSUE WAS REPORTED FOR THIS PRODUCT TO THE FDA 2/2019.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14139640 ↗
• MalfunctionMar 21, 2022Break; Nonstandard Device

  ARTERIAL LINE WAS PLACED ON (B)(6) 2022 THE ARTERIAL PATIENTS LINE DRESSING WAS CHANGED PER PROTOCOL. AFTER REMOVING THE PERVIOUS DRESSING, A STRONG ARTERIAL LINE READING WAS NOTED ON THE MONITOR AND A NEW WAS APPLIED. THE ARTERIAL LINE WAS FUNCTIONING PROPERLY FOR A FEW MINUTES AFTER THE DRESSING CHANGE AS THE ARTERIAL LINE TUBING WAS REMOVED AND IMMEDIATELY IT WAS RECOGNIZED THAT THE MAJORITY OF THE ARTERIAL LINE CATHETER HAD BROKEN ON AND REMAINED IN THE PATIENT ARTERY. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OR FOR REMOVED TO THE RETAINED PORTION OF THE ARTERIAL CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 13839834 ↗

Other Argon Medical Devices, Inc. products

• First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
• BioPince Ultra Full Core Biopsy Instrument10 models · 85 reports · 1 recall
• BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
• L-Cath PICC S/L2 models · 30 reports · 1 recall
• Tru-Core II Biopsy Instrument8 models · 13 reports · 1 recall
• Scorpion2 models · 7 reports · 1 recall
• Tru-Core II URO Biopsy Instrument2 models · 2 reports · 1 recall
• Transvenous Pacing Electrode Tray2 models · 0 reports · 1 recall