Gastrostomy Tube with ENFit connector ENFIT70320Recalls & reported problems
Medline Industries, Inc. · Gastrostomy Tube with ENFit connector, 20FR · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888277411067), received between Nov 10, 2020 and Sep 22, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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
- Physical Resistance/Sticking8
- Burst Container or Vessel7
- Material Rupture2
- Crack1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Crack; Material Split, Cut or Torn
It was reported that "The tubing that is inserted into the stomach cracked on two separate occasions."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854304 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10826000 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10825699 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10825025 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10824390 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10824037 ↗MalfunctionNov 11, 2020Material Rupture; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823741 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10822937 ↗MalfunctionNov 11, 2020Burst Container or Vessel; Physical Resistance/Sticking
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE" WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10822742 ↗MalfunctionNov 10, 2020Material Rupture
IT WAS REPORTED THAT SEVERAL PATIENTS (5-IN TOTAL) HAD EITHER EXPERIENCED THE, "BALLOON BURST OR THE G-TUBE GET SUCKED TO THE INTESTINE," WHILE USING THE ENFIT 3-PORT GASTROSTOMY 20 FR TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10820281 ↗
Other Gastrointestinal Tubes With Enteral Specific Connectors devices
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- 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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