Skip to content

Argyle 8888160358Recalls & reported problems

Cardinal Health, Inc. · PVC Umbilical Vessel Catheter Single Lumen 3.5 Fr/Ch (1.2 mm) x 9-8/10in (25 cm) · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884527020529), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 8, 2019Break; Break

    THE CUSTOMER STATES THE UMBILICAL VESSEL CATHETER WAS INSERTED AND THE LINE WAS FOUND TO HAVE RESISTANCE WITH SOME BLOOD CLOTS FOUND INSIDE THE TUBING. THE MEDICAL PROFESSIONALS CLAMPED THE LINE (COATED WITH GAUZE) WITH AN ARTERY FORCEPS AND CHANGED THE EXTERNAL ACCESSORIES (EXTENSION TUBE AND THREE-WAY STOPCOCK). AFTER RELEASING THE ARTERY FORCEPS, THE LINE WAS FOUND BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8229197 ↗

Other CATHETER, UMBILICAL ARTERY devices

All CATHETER, UMBILICAL ARTERY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.