Gastrostomy Tube with ENFit connector ENFIT70316Recalls & reported problems
Medline Industries, Inc. · Gastrostomy Tube with ENFit connector, 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 10888277411043), received between Sep 25, 2023 and Dec 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- Material Puncture/Hole1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- 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.
MalfunctionDec 29, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE PATIENT'S GASTRIC TUB HAD COME OUT, AND IT WAS DISCOVERED THAT THERE WAS A "PIN HOLE LEAK" IN THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907250 ↗MalfunctionSep 25, 2023Material Integrity Problem; Material Integrity Problem
TUBE SLID OUT AND REQUIRED REPLACEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17814040 ↗
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- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.