EndoVive Safety PEG Kit M00509020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729880424), received between Oct 30, 2020 and Jul 20, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883980 ↗
• MalfunctionJul 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883978 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE TO PROVIDE NUTRITIONAL SUPPORT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE DURING PULL PORTION. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PULL WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473070 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE SPECIFIC DATE IS UNKNOWN. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PEG TUBE AND THE WIRE LOOP (WHILE ATTACHED TO THE PEG TUBE) COMPLETELY SNAPPED OFF WHEN THE PHYSICIAN WAS TRYING TO PULL THE PEG TUBE THROUGH THE INCISION. THE PHYSICIAN ATTEMPTED TO USE A HEMOSTAT TO PULL THE PART OF THE TUBE STILL COMING OUT OF THE PATIENT AND THE REST OF THE WIRE BROKE OFF. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE LOOP WIRE WAS BROKEN AND WAS DETACHED FROM THE CONNECTING WIRE. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719719 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN INITIAL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT WHEN THE PHYSICIAN PULLED THE PEG TUBE THROUGH THE GASTRIC WALL, THE PULL WIRE BROKE. THEY PHYSICIAN WAS ABLE TO GRAB THE BROKEN LOOP WITH HEMOSTATS AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548029 ↗
• MalfunctionOct 30, 2020Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PULL METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PEG TUBE WAS DIFFICULT TO PULL THROUGH THE STOMA. THE PHYSICIAN INTRODUCED THE TROCAR HOWEVER AN INITIAL INCISION WAS NOT DONE FIRST. REPORTEDLY, PROBLEMS BEGAN WHEN INCISIONS WERE MADE ALONGSIDE THE TUBING WHILE TRYING TO PULL THE TUBE THROUGH THE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THE DFU FOR ENDOVIVE SAFETY PEG KIT PULL METHOD FOURTH STEP STATES THE FOLLOWING: USING THE EXPOSED BLADE OF THE SAFETY SCALPEL PROVIDED, MAKE A 1 TO 1.5 CM INCISION AT THE SELECTED INCISION SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10766526 ↗