Argyle 8888160333 (UDI 10192253040302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10192253040302), received between Mar 24, 2025 and Sep 11, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 2, 2025Open, Classified

   Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

   Z-1872-2025 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Connection Problem

  The customer reported that the umbilical catheter end did not secure properly to the stopcock. One retained sample reportedly appeared to be missing part of the lip at the catheter end. The clinical staff reported difficulty achieving a secure connection with the stopcock. Additional information was received from the customer and stated that the issue seemed to occur while the line was on. It appeared the lip at the end of the catheter may have been stripped away. There was no harm reported. Unfortunately, the customer did not have any more additional information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731551 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED AIR/OXYGEN IN THE LINE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY DID NOT OBSERVE ANY CRACKS, HOLES OR BREAKS IN THE LINE. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771353 ↗
• MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER NOTED TO BE LEAKING IV FLUIDS AT THE CONNECTION BETWEEN THE CATHETER AND THE BUTTERFLY PLASTIC CLIP PORTION. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025884 ↗
• MalfunctionJun 12, 2025Break; Connection Problem; Break; Connection Problem

  THE CUSTOMER REPORTED THAT THREADING ON PORTION OF THE CATHETER WHERE THE SYRINGE OR CONNECTORS INSERT WAS BROKEN OFF, THE CONNECTOR COULD NOT BE SECURED TO CATHETER. IT LOOKS AS IF THE UMBILICAL LINE APPARENTLY FAILED DUE TO THE THREADING ON THE CATHETER BEING CHANGED, AS THEY ARE NOW TABS INSTEAD OF THREADS. THERE IS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195333 ↗
• MalfunctionApr 25, 2025Connection Problem; Connection Problem

  THE CUSTOMER REPORTED DEFECTIVE CONNECTOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909355 ↗
• MalfunctionMar 28, 2025Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE LUR-LOCK END OF UMBILICAL ARTERIAL CATHETER (UAC) WOULD NOT SCREW TIGHT TO TRANSDUCER END (SPINNING IN CONTINUOUS CIRCLE WITHOUT LOCKING). THE CUSTOMER TRIED ANOTHER TRANSDUCER AND SAME PROBLEM OCCURRED. THE CUSTOMER FURTHER STATED THAT THEY ATTACHED ANESTHESIA EXTENSION TUBING TO UAC ON ONE END AND THE OTHER TO TRANSDUCER. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724827 ↗
• InjuryMar 24, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE NURSE PRACTITIONER (NP) CHANGED THE MALPOSITIONED UMBILICAL VESSEL CATHETER (UVC). THE OLD CATHETER WAS REMOVED, AND A NEW CATHETER WOULD NOT PASS THROUGH LIVER TO IVC/ ATRIAL JUNCTION. THE CATHETER WAS RETRACTED TO LOW LYING AND SUTURED AS APPROXIMATELY 3CM. THE NP WAS FLUSHING/DRAWING FROM LINE AND NOTICED AIR BUBBLES. NP ATTEMPTED TO REMOVE THE LINE, AND THE CATHETER ¿SNAPPED¿ LEAVING APPROXIMATELY 3 CM OF CATHETER IN BABY WITH THE END NOT VISIBLE AT CORD STUMP. THERE WAS NO BLOOD LOSS REPORTED, STAT BABYGRAM WAS ORDERED AND SURGERY WAS CONSULTED. THE RADIOGRAPH DEMONSTRATED THAT THE CATHETER SEGMENT WAS BELOW THE LIVER, BUT NOT IN CORD STUMP. THE BABY MADE NIL PER OS (NPO) AND PERIPHERAL INTRAVENOUS LINE (PIV) X 2 WAS PLACED. THE BABY WAS AIR TRANSPORTED TO LEVINE CHILDREN¿S HOSPITAL IN CHARLOTTE, NORTH CAROLINA FOR PEDIATRIC INTERVENTIONAL SURGERY TO RETRIEVE RETAINED PIECE OF CATHETER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE INITIALLY MALPOSITIONED UMBILICAL VESSEL CATHETER WAS ALSO (B)(4) UMBILICAL CATHETER SNGL LUMEN 3.5FR AND THE SAME BATCH NUMBER 2431800139. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE

  Patient problems: Foreign Body In Patient

  MAUDE report 21680349 ↗