Arterial Line Kit/1 498106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333215577), received between Jun 23, 2021 and Aug 17, 2023 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2023Break; Break

  A RADIAL ARTERIAL LINE WAS INSERTED IN ICU ON THE (B)(6) AND PT TRANSFERRED TO ICU POST OP. ARTERIAL LINE FUNCTIONING PROPERLY ¿ GOOD TRACE AND BLOOD ASPIRATION. SEPARATION OF ARTERIAL CATHETER FROM HUB REQUIRING SURGICAL REMOVAL. AT APPROXIMATELY 0200HRS ON (B)(6) 23 THE ARTERIAL WAVEFORM SUDDENLY DISAPPEARED. ON EXAMINATION OF THE ARTERIAL LINE HUB WAS STILL SUTURED IN AND DRESSING INTACT AND SITE WAS BLEEDING. WHEN DRESSING REMOVED IT WAS FOUND THAT THE ARTERIAL LINE HAS BROKEN. THE DISTAL PART OF THE LINE UNABLE TO BE FOUND. AN XRAY OF THE PATIENTS FOREARM WAS ATTENDED AND THE ARTERIAL LINE HAD DISLODGED IN THE PATIENTS ARTERY. PATIENT WENT TO OPERATING THEATRES FOR REMOVAL OF THE LINE. PT REMAINED NEUROVASCULARLY INTACT THROUGHOUT THE INCIDENT. THE PATIENT WAS COMPLIANT, NOT AGITATED OR MOVING WRIST EXCESSIVELY. THE ARTERIAL WAVEFORM WAS ADEQUATE AND NO SIGN OF DAMPING LEADING UP TO THE ARTERIAL LINE SNAPPING.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17564860 ↗
• MalfunctionDec 12, 2022Break; Entrapment of Device

  THE CONNECTION POINT BETWEEN THE INTRA-ARTERIAL CATHETER AND THE STABILIZING DEVISE WAS BROKEN AND THE CATHETER WAS RETAINED IN THE ARTERY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15960251 ↗
• MalfunctionJun 23, 2021Component Missing

  ON (B)(6) 2021, A FEMALE PATIENT WITH INITIALS HMC AND DATE OF BIRTH (B)(6) 1950, (70 YEARS OLD), HAD AN ARGON ARTERIAL LINE PLACED. ON (B)(6) 2021, THE ART LINE QUIT RECORDING. UPON REMOVAL, IT WAS NOTED THAT A PORTION OF THE CATHETER WAS MISSING. USING THE ULTRASOUND MACHINE, THE RESIDENT SAW THE REMAINING PORTION OF THE CATHETER WITHIN THE LUMEN OF THE RADIAL ARTERY. VASCULAR SURGERY STATES THE PATIENT IS TO UNSTABLE FOR OPERATIVE INTERVENTION. AS OF TODAY, THE HAND IS STABLE WITH ULNAR ARTERY PATENT. HAND SHOWS SOME IMPROVEMENT IN DISCOLORATION OF FINGERTIPS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12054185 ↗

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-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-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-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.
• 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-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.