Argyle 8888160432Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884527005161), received between May 30, 2019 and Jul 19, 2021 — classified as 1 injury, 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2021Break; Break

  THE CUSTOMER REPORTED A UVC FRAGMENT WAS INCIDENTALLY IDENTIFIED IN THE NICU PATIENT¿S AORTA ON IMAGING. THE RN REMOVED THE CATHETER AND NOTED IT WAS NOT INTACT. THE MARKINGS INDICATED THERE WAS 15CM MISSING. THE UVC WAS INSERTED AT ANOTHER HOSPITAL. ADDITIONAL INFORMATION RECEIVED STATED, PER STAFF INTERVIEW, THE STANDARD PROCESS TO REMOVE A UVC IS TO CLIP THE SUTURE AND THEN PULL GENTLY AND SLOWLY ON THE CATHETER FOR REMOVAL. THE RN DIDN'T NOTICE ANYTHING UNUSUAL ABOUT REMOVING THE CATHETER FOLLOWING THIS PROCESS. THE PATIENT WAS TRANSFERRED TO AN OUT OF NETWORK FACILITY AND THE RETAINED ARTERIAL CATHETER WAS REMOVED BY THE IR TEAM. THERE WERE NO IDENTIFIED COMPLICATIONS CAUSED BY THE RETAINED ARTERIAL CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12191994 ↗
• MalfunctionMay 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE UMBILICAL ARTERY CATHETER WAS PLACED IN A ONE DAY OLD MALE PATIENT WEIGHING (B)(6) GRAMS. THE IVFS WERE ATTACHED AND TRANSDUCING APPROPRIATE WAVEFORM AND BP. LAB WAS DRAWN FROM UAC AT THE STOPCOCK CONNECTION WITHOUT INCIDENCE. THERE WAS GOOD BLOOD RETURN AND IT FLUSHED EASILY. APPROXIMATELY 20 MINUTES LATER, THE LINE BEGAN TO BACK UP BLOOD AND IT WAS NOTED THAT THERE WAS LEAKING FROM A CRACK IN THE LINE NEAR THE HUB. THE LINE WAS CLAMPED TO PREVENT BLOOD LOSS AND THE MEDICAL DOCTOR WAS NOTIFIED. THE CATHETER WAS REMOVED BY THE MEDICAL DOCTOR AND REPLACED WITH A NEW UMBILICAL CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655088 ↗