Entuit Thrive EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 22 FRRecalls & reported problems
Xeridiem Medical Devices, Inc. · Entuit Gastrostomy BR Balloon Retention Feeding Tube, 22 FR Ref. Number: SBRD-22 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002356191), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Material Split, Cut or Torn1
Patient problems
- Abscess1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2021Component Missing; Material Split, Cut or Torn
PATIENT PRESENTED TO EMERGENCY DEPARTMENT FROM SKILLED NURSING FACILITY WITH LUMBAR ABSCESS AND POOR NUTRITION. PRIOR TO THE PLACEMENT (INSERTION) OF AN ENTUIT THRIVE GASTROSTOMY TUBE, EXAMINATION BY THE HEALTH CARE PROVIDERS FOUND THAT THE END OF THE DEVICE (NON-FEED HUB) WAS TORN OFF AND MISSING. ANOTHER GASTROSTOMY TUBE WAS USED FOR THE PROCEDURE. PLEASE NOTE THAT PACKAGING FOR THIS DEVICE WAS NOT SAVED. THE LOT NUMBER PROVIDED IN THE PICTURE IS REPRESENTATION FOR WHAT WAS USED, THEY WERE NEXT TO EACH OTHER ON THE STOCKED SHELF.
Patient problems: Abscess
MAUDE report 12376872 ↗
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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