Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection SBRD-18-ENFRecalls & reported problems
Xeridiem Medical Devices, Inc. · Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 18 FR · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002447837), received between Apr 18, 2018 and Jun 7, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Use of Device Problem1
Patient problems
- Pneumoperitoneum1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 2024Use of Device Problem; Use of Device Problem
REPORTED VIA USER FACILITY MEDWATCH (B)(4): RN (REGISTERED NURSE) INADVERTENTLY ADMINISTERED A FLUID BOLUS THROUGH THE BALLOON PORT OF THE G-TUBE CAUSING THE BALLOON TO RUPTURE. THE PATIENT COMPLAINED OF PAIN AND FELT A "POP" SENSATION. A STAT CT CONFIRMED A BALLOON RUPTURE AND PNEUMOPERITONEUM. THE PATIENT WAS TAKEN EMERGENTLY TO THE OR (OPERATING ROOM) FOR EXPLORATORY LAPROTOMY, GASTRIC WEDGE RESECTION, AND GASTROJEJUNOSTOMY TUBE PLACEMENT. THERE ARE 3 PORTS ON THE DEVICE, 1 IS LABELED "5-10ML" (NOT CLEARLY LABELED AS BALLOON PORT), ONE IS LABELED "MED" AND ONE IS LABELED "FEED". THE ORDER FOR THE BOLUS WAS ENTERED AS AN IV ORDER SO THE NURSE USED AN IV BAG OF NS (NORMAL SALINE) AND IV TUBING WHICH WAS ABLE TO BE ATTACHED TO THE BALLOON PORT.
Patient problems: Pneumoperitoneum
MAUDE report 19492642 ↗InjuryApr 18, 2018Fracture; Fracture
OVER THE PAST SEVERAL WEEKS, (B)(6) HAS HAD NUMEROUS PATIENTS WITH ENTUIT GASTROSTOMY TUBE RETURN TO OUR FACILITY DUE TO THE "ENFIT" CAPS BREAKING ON THE TUBES THAT WERE PLACED. THIS DEFECT PRESENTS A DELAY IN PATIENT CARE, AS WELL AS A POTENTIAL RISK FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7441807 ↗
Other Tubes, Gastrointestinal (And Accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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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