Arterial Catheter Mini-Kit 498107Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333215584), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PATIENT ADMITTED ON (B)(6) 2023 AND ARTLINE WAS INSERTED ON (B)(6) 2023, NO ISSUES NOTED ON INSERTION, GOOD WAVE LINE ETC NOTED. ARTLINE WORKED NORMALLY UNTIL MORNING ON (B)(6) 2023. ON (B)(6) 2023, NURSES WERE CONCERNED WITH READINGS ON THE MONITOR AND INVESTIGATED AND NOTICED BLOOD ACCUMULATED AND SPURTING FROM THE RADIAL ACCESS SITE AND THAT THE RADIAL ARTLINE HAD DETACHED WHILST ON PATIENT¿S ARM & THE LINE IS LEFT IN THE ARM. (NOTE: LINE IS STILL IN THE ARM AND WILL BE SURGICALLY REMOVED DURING THE NEXT FEW DAYS). PROCEDURE STAGE (SELECT ONE): BEFORE USE/PATIENT CONTACT/PRE-OP DURING USE/PROCEDURE/INTRA-OP AFTER INITIAL USE/PATIENT TREATMENT N/A (PRODUCT NOT USED) WERE ACCESSORY DEVICES OR OTHER MANUFACTURER¿S.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17482526 ↗

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-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-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-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-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-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-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-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.