Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection SBRD-14-ENFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002447813), received between Oct 17, 2017 and Jun 6, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Issue” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2018Torn Material; Torn Material

  THE TUBE WAS IN PLACE LESS THAN FOUR WEEKS - SPLIT/TEAR IN BALLOON. SUBSEQUENT INFORMATION WAS RECEIVED AS FOLLOWS: CATHETER WAS REMOVED AND 14FR HALYARD GASTROSTOMY DEVICE WAS INSERTED VIA EXISTING TRACT. GASTRIC ASPIRATE OBTAINED WITH PH=2. HOWEVER, AS TUBE HAS BEEN IN PLACE LESS THAN FOUR WEEKS, A TUBOGRAM WILL BE REQUIRED TO CONFIRM CORRECT POSITION PRIOR TO USE. TUBE REMAINS AT 6CM SKIN LEVEL. ENTRY SITE RED, PAINFUL, INFLAMED AND FIRM TO THE TOUCH - PERISTOMAL ABSCESS. CURRENTLY ON CLINDAMYCIN, GENTAMICIN AND FLUCLOXACILLIN FOLLOWING SKIN SWAB.

  Patient problems: Discomfort

  MAUDE report 7576460 ↗
• InjuryOct 17, 2017Device Issue; Device Issue

  THERE WAS A VERY BAD ABSCESS AND ANTIBIOTICS WERE STARTED. THERE WAS LEAKAGE AT THE MED PORT AND IT WAS VERY DIFFICULT TO MOVE EXTERNAL FIXATOR, TRACT LENGTH 8 CM.

  Patient problems: Abscess

  MAUDE report 6956568 ↗