Argyle 43311 (UDI 20884527004680)Recalls & reported problems
Cardinal Health, Inc. · Peripheral Inserted Central Catheter (PICC) Insertion Tray,Dual Lumen · Class 2
All models of Argyle (64)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884527004680), received between Feb 24, 2020 and Mar 3, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PICC CATHETER WAS LEAKING FROM THE LINE. THE CUSTOMER NOTICED A PIN HOLE AT THE JUNCTION. THE INDWELLING TIME OF THE CATHETER WAS 12 DAYS. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11403899 ↗MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE PICC DISCOVERED UPON HOOKUP OF NEW DRIPS. THE PICC HAD LIPIDS RUNNING AT 1 ML/HR WITH NO ISSUE/LEAKING; HOWEVER, WHEN NEW DRIPS HOOKED UP AT A TOTAL OF 10.5 ML/HR COMBINED, THE PICC WAS FOUND TO HAVE A STEADY LEAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9747194 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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