Argyle 460802ERecalls & reported problems
Cardinal Health, Inc. · Feeding Tube · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521547223), received between Apr 21, 2023 and Jul 22, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 reports).
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
- Material Separation2
- Break1
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE TUBE IN THE PACKAGE HAS BEEN CUT WHEN PACKAGING FROM MANUFACTURER WHEN THE PACKAGE WAS SEALED AND CUT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22566336 ↗MalfunctionOct 16, 2024Break; Break
THE CUSTOMER REPORTED THE 5FR ARGYLE FEEDING TUBE HAD ABOUT A 2CM HOLE IN IT. IT WAS NOTICED OPEN OPENING AND WAS NOT USED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20463977 ↗MalfunctionOct 10, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THEY REMOVED FEEDING TUBE FROM PACKET AND WRAPPED AROUND FINGER TO INSERT IN NEWBORN AND THE TUBING BROKE INTO TWO PIECES. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20422798 ↗MalfunctionApr 21, 2023Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED AN INFANT WAS BEING FED PURAMINO FORMULA WHEN THE NG TUBE BLOCKED PARTWAY THROUGH THE FEED. THE NG TUBE WAS PULLED AND REPLACED WITH A 6.5F NG TUBE. PURAMINO FORMULA NOTED "CONGEALED" AT THE TIP OF THE NG TUBE WHEN REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16787692 ↗
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- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.