Argyle 461008 (UDI 20884521067360)Recalls & reported problems
Cardinal Health 200, LLC · Feeding Tube • Radiopaque · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521067360), received between Jul 2, 2018 and May 27, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Kinked” (4 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.
Most reported problems
Device problems
- Kinked4
- Material Twisted/Bent1
Patient problems
- No Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2021Material Twisted/Bent; Material Twisted/Bent
PER PATIENT ONE OF THE TUBES WAS CRIMPED AND ITS RESTRAINING OR BLOCKING THE FLOW OF THE FLUID. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11894152 ↗MalfunctionJul 3, 2018Kinked; Kinked
THE CUSTOMER REPORTED THE CATHETER HAD COLLAPSED, WHICH COMPLETELY BLOCKED THE LUMEN. THE CATHETER SEEMS TO HAVE BEEN CRUSHED AND MELTED.
Patient problems: No Information
MAUDE report 7658124 ↗MalfunctionJul 2, 2018Kinked; Kinked
THE CUSTOMER REPORTED THE CATHETER HAD COLLAPSED, WHICH COMPLETELY BLOCKED THE LUMEN. THE CATHETER SEEMS TO HAVE BEEN CRUSHED AND MELTED.
Patient problems: No Information
MAUDE report 7655880 ↗MalfunctionJul 2, 2018Kinked; Kinked
THE CUSTOMER REPORTED THE CATHETER HAD COLLAPSED, WHICH COMPLETELY BLOCKED THE LUMEN. THE CATHETER SEEMS TO HAVE BEEN CRUSHED AND MELTED.
Patient problems: No Information
MAUDE report 7655874 ↗MalfunctionJul 2, 2018Kinked; Kinked
THE CUSTOMER REPORTED THE CATHETER HAD COLLAPSED, WHICH COMPLETELY BLOCKED THE LUMEN. THE CATHETER SEEMS TO HAVE BEEN CRUSHED AND MELTED.
Patient problems: No Information
MAUDE report 7655815 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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