Entuit Thrive EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 20 FRRecalls & reported problems
Xeridiem Medical Devices, Inc. · Entuit Gastrostomy BR Balloon Retention Feeding Tube, 20 FR Ref. Number: SBRD-20 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00827002356184), received between Aug 2, 2023 and Mar 11, 2025 — classified as 2 malfunctions.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025
IN RADIOLOGY, THE G-TUBE WAS REMOVED FROM THE PACKAGING. TOOK THE TAG OFF OF THE PLUG AND THE PLUG CAME OFF. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572599 ↗MalfunctionAug 2, 2023
ELDERLY MALE, MENTALLY HANDICAPPED AND RECENT DECREASED APPETITE, UROSEPSIS AND METABOLIC ENCEPHALOPATHY. PROCEDURE: GASTRO TUBE INSERTION. THE RETENTION BALLOON BROKE WHILE INFLATING UNDER FLUOROSCOPY. BOTH PIECES REMOVED WITHOUT KNOWN HARM TO PATIENT. A NEW ONE PLACED WITHOUT DIFFICULTY. MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), ENTUIT THRIVE (PER SITE REPORTER): WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17441704 ↗
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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