EndoVive Jejunal Feeding Tube M00566340Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729789666), received between Mar 13, 2018 and Jan 11, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE JEJUNAL FEEDING TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, ONCE THE JEJUNAL TUBE WAS IN PLACE IT WAS TESTED, A LEAK WAS NOTED IN THE TUBING. THE PROCEDURE WAS COMPLETED WITH A NEW JEJUNAL TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139419 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE JEJUNAL FEEDING TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE JEJUNAL TUBE SNAPPED. A NEW ENDOVIVE JEJUNAL FEEDING TUBE WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102506 ↗
• InjuryMar 25, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS USED DURING A JEJUNAL TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE JEJUNAL TUBE WAS INSERTED VIA AN ENDOVIVE SAFETY PEG TUBE, THE PLASTIC TIP DETACHED INSIDE THE PATIENT. THE DETACHED PORTION WAS RETRIEVED ENDOSCOPICALLY USING FORCEPS. ALSO, IT WAS NOTICED THAT THE JEJUNAL TUBE WAS DIFFICULT TO ADVANCE INTO THE SMALL INTESTINE. THEY THEN DECIDED TO DISCONTINUE THE PLACEMENT. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567546 ↗
• InjuryMar 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED DURING A GASTROSTOMY REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, POST-PROCEDURE AND BEFORE DISCHARGE, THE NUTRIENTS COULD NOT BE INJECTED INTO THE FEEDING TUBE. AN ENDOSCOPE WAS USED TO SEE THERE WAS A BEND IN THE FEEDING TUBE. THE PHYSICIAN WAS ABLE TO UNBEND THE JEJUNAL TUBE AND THE FLOW RETURNED TO NORMAL. HOWEVER, THE PHYSICIAN DECIDED THE FEEDING TUBE NEEDED TO BE REPLACED WITH A NEW ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409006 ↗
• MalfunctionMar 30, 2020Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE JEJUNAL FEEDING TUBE WAS PLACED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JEJUNAL TUBE HAS AN OCCLUSION. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE JEJUNAL FEEDING TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 6, 2020. THERE WAS A SHARP ANGULATION AT THE DISTAL END OF THE PROBE, WHICH PREVENTED THE PASSAGE OF THE GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898487 ↗
• MalfunctionJun 4, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY JEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JEJUNAL TUBE WAS ADVANCED TO THE JEJUNUM. UPON PLACING THE JEJUNAL TUBE IN THE PROPER PLACEMENT, THEY WERE NOT ABLE TO ADVANCE ANY SALINE, FOOD BOLUS OR ANYTHING THROUGH THE FEEDING TUBE AS IT WAS BLOCKED/OCCLUDED. SINCE THE SAME DEVICE IS NOT AVAILABLE, THEY JUST REMOVED THE JEJUNAL TUBE AND KEPT THE PEG TUBE IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567114 ↗
• MalfunctionMar 13, 2018Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER PLACEMENT WAS PERFORMED, TUBE BLOCKAGE OCCURRED FREQUENTLY DUE TO KINK, AND THE KINK ISSUE WAS RESOLVED USING A BIOPSY FORCEPS THROUGH ENDOSCOPE. RECURRENCE OF ISSUE WITHIN A WEEK WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7335969 ↗