Argyle 460604ERecalls & reported problems
Cardinal Health, Inc. · Feeding Tube Radiopaque · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521547209), received between Sep 29, 2021 and Apr 23, 2025 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Leak/Splash1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Break; Break
THE CUSTOMER REPORTED THERE APPEARED TO BE A CRACK WHERE THE PURPLE TOP PIECE CONNECTS WITH THE CLEAR PLASTIC TUBE. THIS ISSUE HAPPENED WITH A NICU NURSE (KVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896013 ↗MalfunctionApr 10, 2023Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT THERE WAS FEED LEAKING AT THE CONNECTION TO THE TUBING, UNDER PURPLE CAP. THEY HAD TO REMOVE THE TUBE AND INSERT NEW ONE. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AFTER THE TUBE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16710391 ↗MalfunctionSep 29, 2021Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE PRODUCT WON¿T ALLOW THE MEDICINE TO GO THROUGH. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12546218 ↗
Other Gastrointestinal Tubes with Enteral Specific Connectors devices
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Standard PEG Kit M00509050Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
- Salem Sump 8888268060ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall0 reports
- Salem Sump 7771810ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.