CARDINAL HEALTH 8884720205ERecalls & reported problems
Cardinal Health 200, LLC · Gastrostomy Feeding Tube With ENFit Y-Port 20 Fr/Ch (6.7 mm) with 20 mL Balloon · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253068801), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Deflation” (1 report).
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 Deflation1
Patient problems
- Fever1
- High White Blood Cell Count1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Unintended Deflation
THE CUSTOMER REPORTED DURING PATIENT ADMISSION, THEY UNDERWENT LAPAROSCOPIC PROCEDURES INCLUDING G [GASTRIC] TUBE PLACEMENT, DIAGNOSTIC LAPAROSCOPY, AND CHOLECYSTECTOMY. A CT SCAN REVEALED THAT THE END OF THE G TUBE COULD NOT BE IDENTIFIED. SUBSEQUENT ATTEMPTS BY THE SURGICAL TEAM TO DEFLATE THE BALLOON WERE UNSUCCESSFUL, INDICATING A POSSIBLE RUPTURE. THIS COMPLICATION LIKELY LED TO THE SYMPTOMS OF INCREASING WBC, FEVERS, AND POSITIVE BLOOD CULTURES, SUGGESTIVE OF TUBE FEEDS POTENTIALLY ENTERING THE ABDOMEN. THE COMPROMISED BALLOON NECESSITATES A SURGICAL REPLACEMENT OF THE G TUBE.
Patient problems: Fever; High White Blood Cell Count; Unspecified Infection
MAUDE report 24709468 ↗
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-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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.
How reports and recalls are matched · Editorial policy · Report an error on this page