Gastrostomy Tube with ENFit connector ENFIT70322Recalls & reported problems
Medline Industries, Inc. · Gastrostomy Tube with ENFit connector 22FR · 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 10888277411074), received between Nov 20, 2017 and Nov 20, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Deflation Problem1
Patient problems
- Ulcer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2017Deflation Problem
IT WAS REPORTED A GASTROSTOMY TUBE RETENTION BALLOON DEFLATED AND NEEDED TO BE REPLACED.
Patient problems: Ulcer
MAUDE report 7046366 ↗
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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