Arterial Line Kit 498411BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333215652), received between Mar 21, 2022 and Apr 19, 2022 — classified as 2 malfunctions.

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

11 other recalls cover devices cleared under the same FDA submission (K780871); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780871. One submission often covers many models, so check the product and lot details in each record.

• Z-2708-2026 · Jun 1, 2026 · Open, Classified
  Arterial Line Kit 20ga x 6, REF: 400115A
• Z-0563-2022 · Jan 24, 2022 · Open, Classified
  1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
• Z-1937-2020 · Apr 8, 2020 · Terminated
  Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous in
• Z-1936-2020 · Apr 8, 2020 · Terminated
  Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous i
• Z-1741-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1740-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1743-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1745-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1742-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1737-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669.
• Z-1744-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.