Gastrostomy Tube with ENFit connector ENFIT70318Recalls & reported problems
Medline Industries, Inc. · Gastrostomy Tube with ENFit connector, 18FR · 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 10888277411050), received between Nov 28, 2023 and Sep 19, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unintended Extubation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832729 ↗MalfunctionNov 28, 2023Deflation Problem; Deflation Problem
"IT WAS INSERTED INTO A PATIENT AND THE BALLOON DEFLATED".
Patient problems: Unintended Extubation
MAUDE report 18217479 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.