Covidien 8884720189ERecalls & reported problems
Cardinal Health, Inc. · True content to be populated as part of rebranding · Class 2 · Implant
All models of Covidien (7)
Data updated Oct 16, 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 10884521661707), received between Jun 4, 2024 and Apr 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation2
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Unintended Deflation
THE CUSTOMER REPORTED ONE DAY AFTER THE PROBE WAS INSERTED, IT BECAME EXTERNALIZED. UPON INFLATING THE BALLOON, IT WAS RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028144 ↗MalfunctionJun 4, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE HCAS WERE PROVIDING MORNING CARE TO RESIDENT AND HAD JUST TURNED HER ONTO HER BACK WHEN SHE HELD OUT HER GT TUBE WHICH WAS IN HER HAND. HCAS IMMEDIATELY CALLED WRITER WHO INSERTED A NEW GT TUBE WITHOUT DIFFICULTY. MINIMAL BLEEDING NOTED AT GT STOMA. WHEN THEY ASKED THE RESIDENT HOW TUBE CAME OUT, SHE JUST SHRUGGED. RESIDENT DENIED ANY PAIN. INCIDENT REPORTED TO MANAGER AS OLD TUBE WAS FOUND TO HAVE HOLE IN BALLOON AND HAD JUST BEEN INSERTED TWO DAYS BEFORE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19457962 ↗
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
- 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
- NutraGlide Nasal Feeding Tube ENFT-06055-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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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