CARDINAL HEALTH 8884720221ERecalls & reported problems
Cardinal Health 200, LLC · Gastrostomy Feeding Tube With ENFit Y-Port 22 Fr/Ch (7.3 mm) with 20 mL Balloon · Class 2 · Implant
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 10192253068818), received between Mar 12, 2026 and Mar 12, 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 18, 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.
MalfunctionMar 12, 2026Unintended Deflation
THE CUSTOMER REPORTED THE G-TUBE BALLOON RUPTURED. IT WAS REPLACED WITH A NEW 8884720221E G-TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587163 ↗MalfunctionMar 12, 2026Unintended Deflation
THE CUSTOMER REPORTED THEY HAVE RECENTLY OBSERVED AN INCREASED INCIDENCE OF BALLOON RUPTURE RESULTING IN TUBE DISLODGEMENT. THE CURRENT INCIDENT OCCURRED ON FEBRUARY 28TH BEFORE THE START OF FEEDING AT 1600HR. THE DEVICE CAME OUT AND IT WAS FOUND THAT THE BALLOON HAD ALREADY RUPTURED. IT WAS REPLACED WITH ANOTHER G-TUBE OF THE SAME ITEM CODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584830 ↗
Other Gastrointestinal Tubes with Enteral Specific Connectors devices
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Standard PEG Kit M00509050Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
- Salem Sump 8888268060ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall0 reports
- Salem Sump 7771810ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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