Entuit Thrive EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 18 FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002356177), received between Apr 27, 2018 and Dec 6, 2024 — classified as 2 deaths, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) EMAILED, CUSTOMER REPORTED PEG PROBE PLACEMENT ON (B)(6) .2024 ON 8.11 RE-PRESENTATION BECAUSE FOOD PROTRUDES NEXT TO THE TUBE, ON EXAMINATION IT WAS SHOWN THAT THE PEG TUBE WAS NO LONGER IN SITU; IN THE CASE OF THE REMOVED PEG PROBE, AN EXTERNAL PLATE WAS VISIBLE INSIDE T-TUBE WITHOUT AN ANTIMICROBIAL PLATE, REPORTED LOT NOT ON EOSKS, LOGGED AGAINST LAST SHIPPED ORDER. BASED OFF OF THIS STATEMENT IN THE REPORT "WHEN THE PEG TUBE WAS REMOVED, THERE WAS AN EXTERNAL PLATE INSIDE THE T-TUBE WITHOUT A COUNTER PLATE" CAN YOU POINT OUT THE AFFECTED AREA? BECAUSE FOOD HAS ESCAPED FROM THE CREATED TRACT, IT WAS SLIGHTLY RED. THAT'S WHY THE PAT WENT BACK TO THE HOSPITAL.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 20871921 ↗
• InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE AUSTRIAN FEDERAL OFFICE FOR SAFETY IN HEALTH CARE EMAILED, CUSTOMER REPORTED: AFTER INSERTING THE PEG TUBE ON (B)(6) 2024, THE PATIENT HAD PAIN AND COAGULATED BLOOD AROUND THE PEG TUBE. IN THE CT ABDOMEN, THE PEG PROBE WAS DISLOCATED OUTSIDE THE STOMACH, THE CATHETER TIP WAS AGAINST THE OUTER STOMACH WALL, THE BALLOON INTACT (5ML). PAT. HAD TO BE ACUTELY ADMITTED TO THE OPERATING ROOM FOR (B)(6). EXPORTATION WITH NEW INSTALLATION OF A GASTRIC-TUBE, LOT CONFIRMED.

  Patient problems: Abdominal Pain; Gastrointestinal Hemorrhage

  MAUDE report 20866718 ↗
• InjuryFeb 1, 2024Material Rupture; Material Rupture

  G-TUBE WAS PLACED ON (B)(6)2023; WITHIN 30 HOURS IT SHOWED ON CT THAT THE DEVICE BALLOON HAD APPARENTLY RUPTURED. STOMA TRACT CLOSED AS A RESULT AND PATIENT HAD TO GO TO GI LAB TO HAVE THE TUBE REPLACED ON (B)(6)2023.

  Patient problems: Erosion

  MAUDE report 18628127 ↗
• DeathNov 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ENTUIT TUBE PLACED (B)(6). RETENTION BALLOON INFLATED. FEEDS PER TUBE INITIATED (B)(6). ON (B)(6), PT WITH SEVERE ABD PAIN, CT SHOWED MIGRATION OF TUBE OUTSIDE OF STOMACH AND BALLOON DEFLATED. PT TO OR FOR PERITONEAL LAVAGE. RESULTED IN PERITONITIS/SEPSIS. PT MADE DNR AND EXPIRED (B)(6) 2018.

  Patient problems: Death

  MAUDE report 8064310 ↗
• DeathOct 30, 2018Migration or Expulsion of Device

  ENTUIT TUBE PLACED (B)(6) 2018. RETENTION BALLOON INFLATED. FEEDS PER TUBE INITIATED (B)(6). (B)(6), PT WITH SEVERE ABD PAIN, CT SHOWED MIGRATION OF TUBE OUTSIDE OF STOMACH AND BALLOON DEFLATED. PT TO OPERATING ROOM FOR PERITONEAL LAVAGE. RESULTED IN PERITONITIS/SEPSIS. PT MADE DNR AND EXPIRED (B)(6) 2018.

  Patient problems: Death

  MAUDE report 8028950 ↗
• InjuryJun 1, 2018Device Handling Problem; Device Handling Problem

  THE INTERVENTIONAL RADIOLOGY DEPARTMENT HAS PLACED THREE ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY TUBES IN THE LAST 6 MONTHS THAT HAVE BECOME DISLODGED OR FALLEN OUT BECAUSE SOMETHING WAS ATTACHED TO THE BALLOON PORT, WHICH IS NOT LABELED, CAUSING THE BALLOON TO DEFLATE. THE BALLOON IS A RETENTION BALLOON TO KEEP THE TUBE IN THE STOMACH. THE DISLODGED TUBE RESULTED IN A PATIENT HAVING TO HAVE A SURGICAL PROCEDURE; THE OTHER 2 HAD TO HAVE THE TUBES REPLACED. THE PORT IS NOT LABELED AS A BALLOON, WHILE THE OTHER 2 PORTS ARE LABELED AS MEDICINE PORT AND FEEDING PORT. THE PATIENT INVOLVED IN THIS EVENT REQUIRED SURGICAL INTERVENTION.

  Patient problems: Feeding Problem

  MAUDE report 7563503 ↗
• MalfunctionApr 27, 2018Deflation Problem; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  THE INTERVENTIONAL RADIOLOGY DEPARTMENT HAS PLACED THREE ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY TUBES IN THE LAST 6 MONTHS THAT HAVE BECOME DISLODGED OR FALLEN OUT BECAUSE SOMETHING WAS ATTACHED TO THE BALLOON PORT, WHICH IS NOT LABELED, CAUSING THE BALLOON TO DEFLATE. THE BALLOON IS A RETENTION BALLOON TO KEEP THE TUBE IN THE STOMACH. ONE DISLODGED TUBE RESULTED IN A PATIENT HAVING TO HAVE A SURGICAL PROCEDURE; THE OTHER 2 HAD TO HAVE THE TUBES REPLACED. THIS PORT IS NOT LABELED AS A BALLOON, WHILE THE OTHER 2 PORTS ARE LABELED AS MEDICINE PORT AND FEEDING PORT. THE PATIENT INVOLVED IN THIS EVENT REQUIRED REPLACEMENT OF THEIR G-TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7468244 ↗
• MalfunctionApr 27, 2018Deflation Problem; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  THE INTERVENTIONAL RADIOLOGY DEPARTMENT HAS PLACED THREE ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY TUBES IN THE LAST 6 MONTHS THAT HAVE BECOME DISLODGED OR FALLEN OUT BECAUSE SOMETHING WAS ATTACHED TO THE BALLOON PORT, WHICH IS NOT LABELED, CAUSING THE BALLOON TO DEFLATE. THE BALLOON IS A RETENTION BALLOON TO KEEP THE TUBE IN THE STOMACH. ONE DISLODGED TUBE RESULTED IN A PATIENT HAVING TO HAVE A SURGICAL PROCEDURE; THE OTHER 2 HAD TO HAVE THE TUBES REPLACED. THIS PORT IS NOT LABELED AS A BALLOON, WHILE THE OTHER 2 PORTS ARE LABELED AS MEDICINE PORT AND FEEDING PORT. THE PATIENT INVOLVED IN THIS EVENT REQUIRED SURGICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7468206 ↗
• MalfunctionApr 27, 2018Deflation Problem; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  THE INTERVENTIONAL RADIOLOGY DEPARTMENT HAS PLACED THREE ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY TUBES IN THE LAST 6 MONTHS THAT HAVE BECOME DISLODGED OR FALLEN OUT BECAUSE SOMETHING WAS ATTACHED TO THE BALLOON PORT, WHICH IS NOT LABELED, CAUSING THE BALLOON TO DEFLATE. THE BALLOON IS A RETENTION BALLOON TO KEEP THE TUBE IN THE STOMACH. ONE DISLODGED TUBE RESULTED IN A PATIENT HAVING TO HAVE A SURGICAL PROCEDURE; THE OTHER 2 HAD TO HAVE THE TUBES REPLACED. THIS PORT IS NOT LABELED AS A BALLOON, WHILE THE OTHER 2 PORTS ARE LABELED AS MEDICINE PORT AND FEEDING PORT. THE PATIENT INVOLVED IN THIS EVENT REQUIRED REPLACEMENT OF THEIR G-TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7468187 ↗