Arterial Line Kit/1 498100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333215539), received between Nov 9, 2021 and Feb 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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.

• InjuryFeb 26, 2025Difficult to Insert; Difficult to Insert

  DURING INSERTION OF BRACHIAL ARTERIAL LINE, THE WIRE WOULD NOT FEED PAST THE HUB. UNSURE IF BLOCKAGE AT HUB OR THE WIRE TOO BIG TO PASS THROUGH HUB. I USED A SMALL WIRE TO NAVIGATE THE BLOCKAGE, AND THEN USING A CANNULA OVER THE SMALL WIRE, WAS THEN ABLE TO INSERT THE LINE. THIS APPROACH WAS USED BASED ON PREVIOUS SCENARIOS. IT IS NOT A DESIRABLE OR ELEGANT SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473890 ↗
• MalfunctionDec 20, 2022Entrapment of Device; Detachment of Device or Device Component

  INSERTED (B)(6) 2022, LEFT BRACHIAL IN PREPARATION FOR CABG SURGERY. PATIENT WEANED FROM VENTILATOR (B)(6) 2022, UNCEREMONIOUSLY, BUT HAD NOT BEEN TRANSFERRED TO BEDSIDE CHAIR DUE TO LABILE BP. AROUND 0730 ON (B)(6) 2022, PATIENT INFORMED ICU RN THAT SHE FELT SOMETHING WET ON HER ARM. SEEING BLOOD AT THE BRACHIAL SITE, RN REMOVED THE DRESSING AND FOUND THE YELLOW HUB OF THE BRACHIAL LINE, ALONE AND SLIGHTLY OFFSET FROM THE INSERTION SITE. NURSE SEARCHED FOR THE CATHETER IN THE BED, COULD NOT LOCATE IT AND NOTIFIED THE SURGEON AS THE PATIENT C/O A ¿PINCHING¿ SENSATION IN HER ARM. PATIENT TAKEN BACK TO OR AND CATHETER RETRIEVED FROM LEFT ARM VASCULATURE. SPECIMEN SENT TO PATHOLOGY FOR IDENTIFICATION AND WORKUP. NO ADDITIONAL INJURY NOTED AND PATIENTS LEFT ARM RADIAL PULSE WAS NEVER IMPACTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16016836 ↗
• MalfunctionNov 9, 2021Defective Device

  PER MD - DEFECTIVE ¿ THE SUPPLIES IN EACH KIT DO NOT MATCH WHAT IS ON THE BOX AND THEY WERE MADE DEFECTIVE. IN EACH KIT, THERE IS A FINDER NEEDLE, THEN A GUIDE WIRE THAT GOES THRU THE NEEDLE, THEN A CATHETER THAT GOES OVER THE WIRE. IN ALL CASES IDENTIFIED, THE GUIDEWIRES WERE UNABLE TO BE THREAD INTO THE NEEDLE WHILE THE NEEDLE IS ALREADY IN A PULSATING ARTERY. IN ONE OF THE CASES, THE GUIDE WIRE WAS ABLE TO BE INSERTED THRU THE NEEDLE, BUT THE CATHETER DID NOT FIT OVER THE WIRE, WHICH RESULTED IN US PULLING ANOTHER BIGGER GAUGE CASE/CATHETER TO SLIP OVER THE WIRE. IN SUMMARY, MULTIPLE INSTANCES HAVE OCCURRED WHERE THE 3 COMPONENTS ARE NOT OF THE SAME SIZE (EITHER 18G OR 20G) OR MADE SO IN THAT THEY DON¿T PROPERLY FIT. THIS RESULTING IN HARM TO THE PATIENT, TIME LOST, MULTIPLE POKES, AND BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783339 ↗

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-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-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-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-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-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-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-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.