EndoVive Jejunal Feeding Tube M00566320Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729786313), received between Sep 21, 2018 and Nov 12, 2025 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD AND ENDOVIVE JEJUNAL FEEDING TUBE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, A FAMILY MEMBER OF THE PATIENT REPORTED THAT THE DEVICE HAD BEEN OBSTRUCTED SINCE IT WAS IMPLANTED AND THAT THE PATIENT FEEDING WAS TAKING MORE THAN THREE HOURS WITHOUT ADMINISTRATION BEING COMPLETED. THE TUBE WAS FLUSHED WITH A 60 ML SYRINGE BEFORE AND AFTER USE, BUT A RESISTANCE WAS FELT EVEN DURING FLUSHING. THE TUBE WAS FLUSHED THREE TIMES, AND THE FEEDING REGIMEN STARTED OVER, BUT AFTER THREE HOURS WAS NOT COMPLETED, WHICH WAS CONSIDERED AS ABNORMAL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE FAMILY MEMBER STATED THAT THEY HAD CALLED AN AMBULANCE FIVE TIMES DUE TO COMPLICATIONS WITH THE FEEDING TUBE HOWEVER, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537953 ↗
• MalfunctionJan 26, 2022Difficult to Remove; Defective Device; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED DURING A GASTROSTOMY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE JEJUNAL TUBE WAS INSERTED ALONG WITH THE GUIDEWIRE. IT WAS THEN ATTEMPTED TO REMOVE THE GUIDEWIRE HOWEVER, IT WAS UNABLE TO DO SO THEREFORE THE JEJUNAL TUBE AS WELL AS THE GUIDEWIRE WAS REMOVED. THE GUIDEWIRE WAS CHECKED OUTSIDE THE BODY AND FOUND IT WAS DEFORMED WHICH CAUSED IT NOT TO BE ABLE TO BE REMOVED FROM THE JEJUNAL TUBE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13360331 ↗
• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS IS THE SECOND OF TWO REPORTS FOR ENDOVIVE JEJUNAL FEEDING TUBES RELATED TO THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2021-02771 FOR THE DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE JEJUNAL FEEDING TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE JEJUNAL TUBE MIGRATED INTO THE STOMACH. ON (B)(6) 2021, WHEN THE JEJUNAL TUBE WAS BEING REPLACED IT BROKE INSIDE THE PEG TUBE. A NEW ENDOVIVE JEJUNAL FEEDING TUBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007693 ↗
• MalfunctionJun 15, 2021Migration; Migration

  NOTE: THIS IS THE FIRST OF TWO REPORTS FOR ENDOVIVE JEJUNAL FEEDING TUBES RELATED TO THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2021-02803 FOR THE DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE JEJUNAL FEEDING TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE JEJUNAL TUBE MIGRATED INTO THE STOMACH. ON (B)(6) 2021, WHEN THE JEJUNAL TUBE WAS BEING REPLACED IT BROKE INSIDE THE PEG TUBE. A NEW ENDOVIVE JEJUNAL FEEDING TUBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005321 ↗
• MalfunctionFeb 10, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  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. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, FLUOROSCOPY WAS PERFORMED TO CONFIRM THE PLACEMENT OF THE DEVICE. IT WAS FOUND THAT THE CONTRAST WAS IN THE STOMACH AS WELL AS IN THE DUODENUM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307590 ↗
• MalfunctionSep 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS USED DURING A JEJUNAL TUBE REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN JEJUNAL TUBE WAS PLACED, THE PHYSICIAN PULLED THE WIRE OUT AND THE ENTIRE INNER TUBE CAME OUT AS WELL. REPORTEDLY, THE WIRE WAS EASY TO PULL. THE PROCEDURE WAS COMPLETED 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 Consequences Or Impact To Patient

  MAUDE report 10514800 ↗
• InjuryDec 20, 2018Leak/Splash; Loose or Intermittent Connection; Migration; Leak/Splash; Loose or Intermittent Connection; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL TUBE WAS USED DURING A JEJUNAL FEEDING TUBE REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE PLACEMENT OF THE TUBE WENT WELL. AFTER THE SEDATION SUBSIDED, THE PATIENT STOOD UP READY TO GO HOME AS THE PROCEDURE WAS ALREADY COMPLETED, IT WAS NOTICED THAT GASTRIC JUICES AND BILE FROM THE PATIENT LEAKED EXCESSIVELY FROM THE PORT OF THE JEJUNAL TUBE. IT WAS FOUND THAT THE PORTS ON THE FEEDING TUBE WHERE THE FOOD IS DELIVERED THROUGH A SYRINGE WAS DESCRIBED AS OVAL SHAPE, INSTEAD OF BEING ROUND. THE PORT COULD NOT BE CLOSED DUE TO THE OVAL SHAPE OF THE PORT. THE PEG TUBE WAS NOT DEFECTIVE, IT WAS ONLY THE JEJUNAL TUBE. ALSO, THE PACKAGING WAS NOT DAMAGED. IT WAS JUST THE PRODUCT INSIDE THE PACKAGE THAT APPEARED DISTORTED. THE PATIENT ALSO EXPERIENCED STOMACH DISTENSION AND ABDOMINAL PAIN WHICH WAS DESCRIBED AS VERY PAINFUL. REPORTEDLY, THE PATIENT HAD GASTROPARESIS  AND VOMITED WHICH CAUSED THE JEJUNAL TUBE  TO MIGRATE UP. THE PATIENT ENDED UP PULLING THE ENTIRE TUBE OUT OF HER MOUTH. WITH HER CONDITION AND WITH WHAT HAPPENED TO HER JEJUNAL TUBE, THE PATIE

  Patient problems: Pain

  MAUDE report 8187166 ↗
• MalfunctionNov 5, 2018Obstruction of Flow; Obstruction of Flow

  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. THE EXACT PROCEDURE DATE WAS UNKNOWN HOWEVER IT WAS REPORTED THAT IT WAS PLACED APPROXIMATELY THREE MONTHS AGO. ACCORDING TO THE COMPLAINANT AFTER MANY WEEKS THE JEJUNAL TUBE BECAME CLOGGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040389 ↗
• InjuryOct 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  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) 2018.   ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE JEJUNAL TUBE WAS INSERTED, THE PLASTIC TIP SNAPPED OFF. THE DETACHED PORTION WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED 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 Consequences Or Impact To Patient

  MAUDE report 7984970 ↗
• MalfunctionSep 21, 2018Material 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 PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS IN USE FOR A MONTH. ACCORDING TO THE COMPLAINANT, THE JEJUNAL TUBE WAS CHECKED DURING A REGULAR REPLACEMENT. DURING THE CHECK UP, THEY WERE ABLE TO ADVANCE THE GUIDEWIRE BUT THE WATER COULD NOT BE INTRODUCED AS THE TIP OF THE TUBE WAS KINKED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899342 ↗