Covidien 8884720163ERecalls & reported problems
Cardinal Health, Inc. · Gastronomy Feed Tube With ENFit Y-Port 16FR · Class 2 · Implant
- 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 10884521661684), received between Sep 26, 2024 and May 21, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT AFTER PLACEMENT IN THE OSTOMY, WHEN INFLATING THE BALLOON WITH PHYSIOLOGICAL WATER, IT EXPLODED AND DID NOT YET REACH THE 20 ML LIMIT (AT 15 ML). THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066849 ↗MalfunctionSep 26, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE GASTROSTOMY TUBE WAS INSERTED ON (B)(6) 2024 AND THE BALLOON RUPTURED ON (B)(6) 2024. THE DEVICE WAS REMOVED, DISCARDED, AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20315495 ↗
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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.