Arterial Catheter Mini-Kit 498101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333215546), received between Feb 1, 2023 and Feb 14, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2023Break; Break

  FOLLOWING CARDIAC SURGERY, A PATIENT PRESENTED TO THE ICU WITH THE NAMED PRODUCT PLACED IN HER LEFT RADIAL ARTERY, WHICH HAD BEEN INSTILLED 4 HOURS EARLIER. LAB PERSONNEL ACCESSED THE LINE TO DRAW POST OP LABS, THEN NOTED TO THE ROOM NURSE THAT THERE WAS SOME BLEEDING FROM THE LINE DRESSING, THE ROOM NURSE INVESTIGATED AND ATTEMPTED TO MANIPULATE THE LINE TO STOP FURTHER BLEEDING. WHEN THIS DID NOT WORK, THE NURSE ATTEMPTED TO REMOVE THE DRESSING TO VISUALIZE THE ISSUE, WHEN THE DRESSING WAS REMOVED, THE HUB OF THE ARTERIAL LINE CAME AWAY FROM THE INSERTION SITE, BUT THE CATHETER REMAINED IN THE PATIENTS RADIAL ARTERY, THE ICU PROVIDERS WERE IMMEDIATELY NOTIFIED TO THE ISSUE, T HE CATHETER WAS NOT VISIBLE BUT IT COULD BE PALPATED UNDER THE SKIN AND VISUALIZED WITH ULTRASOUND, THE PATIENT HAD TO HAVE AN ADDITIONAL PROCEDURE WITH HAND SURGERY TO REMOVE THE CATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16372324 ↗
• InjuryFeb 1, 2023Detachment of Device or Device Component

  FOLLOWING CARDIAC SURGERY, A PATIENT PRESENTED TO THE ICU WITH THE NAMED PRODUCT PLACED IN HER LEFT RADIAL ARTERY, WHICH HAD BEEN INSTILLED 4 HOURS EARLIER. LAB PERSONNEL ACCESSED THE LINE TO DRAW POST OP LABS, THEN NOTED TO THE ROOM NURSE THAT THERE WAS SOME BLEEDING FROM THE LINE DRESSING. THE ROOM NURSE INVESTIGATED AND ATTEMPTED TO MANIPULATE THE LINE TO STOP FURTHER BLEEDING. WHEN THIS DID NOT WORK, THE NURSE ATTEMPTED TO REMOVE THE DRESSING TO VISUALIZE THE ISSUE. WHEN THE DRESSING WAS REMOVED, THE HUB OF THE ARTERIAL LINE CAME AWAY FROM THE INSERTION SITE, BUT THE CATHETER REMAINED IN THE PATIENT'S RADIAL ARTERY. THE ICU PROVIDERS WERE IMMEDIATELY NOTIFIED OF THE ISSUE. THE CATHETER WAS NOT VISIBLE, BUT IT COULD BE PALPATED UNDER THE SKIN AND VISUALIZED WITH ULTRASOUND. THE PATIENT HAD TO HAVE AN ADDITIONAL PROCEDURE WITH HAND SURGERY TO REMOVE THE CATHETER. WE DO STILL HAVE THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16277023 ↗

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-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-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-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-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-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-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.