EndoVive Standard PEG Kit M00509060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729880509), received between Nov 3, 2021 and Dec 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED IN THE ABDOMEN DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FOR ESOPHAGEAL CANCER WITH DYSPHAGIA AND WEIGHT LOSS PERFORMED ON (B)(6) 2025. DURING THE PEG TUBE PLACEMENT PROCEDURE, THE WIRE USED TO PULL THE TUBE THROUGH THE STOMACH SNAPPED AND BROKE. THE DEVICE WAS COMPLETELY REMOVED, AND A NEW PEG TUBE WAS INSERTED. DUE TO THE PROBLEM ENCOUNTERED, THE PATIENT REQUIRED SURGICAL INTERVENTION. THE PATIENT PROCEEDED TO SURGERY FOR FURTHER MANAGEMENT. THE PATIENT HAD NO IMMEDIATE COMPLICATIONS, AND THE PATIENT CONDITION WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23926919 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO SEVEN ENDOVIVE PEG KITS. REFER TO MANUFACTURER REPORT# 3005099803-2021-05723, 3005099803-2021-05724, 3005099803-2021-05725, 3005099803-2021-05726, 3005099803-2021-05727, AND 3005099803-2021-05729 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT THE PATIENTS WERE NOT PULLING THE PEG TUBES OUT OF THEIR STOMA SITES BUT RATHER THEY WERE LOOSE AND FALLING OUT OF THE PATIENTS. A NEW PEG TUBE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743863 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO SEVEN ENDOVIVE PEG KITS. REFER TO MANUFACTURER REPORT# 3005099803-2021-05723, 3005099803-2021-05724, 3005099803-2021-05725, 3005099803-2021-05726, 3005099803-2021-05727, 3005099803-2021-05728 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT THE PATIENTS WERE NOT PULLING THE PEG TUBES OUT OF THEIR STOMA SITES BUT RATHER THEY WERE LOOSE AND FALLING OUT OF THE PATIENTS. A NEW PEG TUBE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743858 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO SEVEN ENDOVIVE PEG KITS. REFER TO MANUFACTURER REPORT# 3005099803-2021-05723, 3005099803-2021-05725, 3005099803-2021-05726, 3005099803-2021-05727, 3005099803-2021-05728 AND 3005099803-2021-05729 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT THE PATIENTS WERE NOT PULLING THE PEG TUBES OUT OF THEIR STOMA SITES BUT RATHER THEY WERE LOOSE AND FALLING OUT OF THE PATIENTS. A NEW PEG TUBE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743737 ↗