Entuit G34443Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002344433), received between Aug 30, 2017 and May 15, 2018 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Air Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED AN ENTUIT START INITIAL PLACEMENT GASTROSTOMY TUBE BURST AND CAME OUT OF A PATIENT. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516082 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Erosion; Inflammation; No Code Available

  MAUDE report 7007596 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Erosion; Inflammation; No Code Available

  MAUDE report 7007588 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Erosion; Inflammation; No Code Available

  MAUDE report 7007586 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, APPROXIMATELY 1 WEEK FOLLOWING THE UNEVENTFUL INSERTION OF A PERCUTANEOUS RADIO-GUIDED GASTROSTOMY, AN OPENING OCCURRED AT THE PERIPHERY OF THE GASTROSTOMY ORIFICE. LEAKAGE OF THE GASTRIC FLUID AND INFLAMMATION OF THE PATIENT'S CUTANEOUS SKIN WERE REPORTED. THE GASTROSTOMY FEEDING TUBE WAS EXCHANGED FOR A LARGER SIZED FEEDING TUBE IN AN ATTEMPT TO RESTORE THE SEAL AT THE GASTROSTOMY SITE. ANTIBIOTICS, SKIN CARE, AND PROTON PUMP INHIBITORS WERE ADMINISTERED. CLINICAL MONITORING WAS PERFORMED AS A PRECAUTION, AND THE USAGE OF THIS DEVICE WAS REPORTEDLY HALTED BY THE CUSTOMER TEMPORARILY. IT IS NOT KNOWN WHETHER OR NOT THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Erosion; Inflammation; No Code Available

  MAUDE report 7007339 ↗
• InjurySep 7, 2017Positioning Problem; Positioning Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN EMPLOYING THE ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET DURING THE PROCEDURE ON (B)(6) 2017, THE GASTROSTOMY BECAME DISPLACED DURING THE FINAL PART OF THE PROCEDURE AND IT HAD TO BE REMOVED. THE GASTROSTOMY WAS LATER RE-ATTEMPTED AND COMPLETED SUCCESSFULLY ON (B)(6) 2017. THE DELAY NECESSITATED THE USE OF A NASOGASTRIC TUBE FOR PATIENT NUTRITION UNTIL THE COMPLETION OF THE SECOND PROCEDURE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. THE CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6847692 ↗
• InjuryAug 31, 2017Air Leak; Air Leak

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT THE OPERATOR MADE 2 OR 3 ATTEMPTS TO PLACE THE FEEDING TUBES USING THE PRODUCT; HOWEVER, AIR WAS LEAKING FROM THE STOMACH. THE PROCEDURE WAS NOT SUCCESSFUL AS A RESULT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED ON THE SAME DAY AS A PRECAUTION. THE PATIENT ELECTED NOT TO HAVE SURGICAL INTERVENTION DUE TO THE RISKS INVOLVED, AND EXPERIENCED SEVERE ABDOMINAL PAIN DUE TO THE FAILURE OF THE DEVICE.

  Patient problems: Pain

  MAUDE report 6834150 ↗
• DeathAug 30, 2017Difficult To Position; Difficult To Position

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO POSITION THE DILATOR WITH THE PEELAWAY SHEATH ADEQUATELY. AS A RESULT, THE GASTROSTOMY WAS NOT PLACED WITHIN THE STOMACH. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED POST PROCEDURE TO CONFIRM THAT THE STOMACH WAS PERFORATED, AND TO CONFIRM THE PRESENCE OF PNEUMOPERITONEUM. THE DECISION WAS THEN MADE REGARDING THE PATIENT "TO TREAT CONSERVATIVELY AND MAKE COMFORTABLE UNTIL DEATH." THE PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Death

  MAUDE report 6831858 ↗