EndoVive Standard PEG Kit M00509070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729880523), received between Jan 26, 2022 and Jan 13, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN ADVANCING THE PEG TUBE OVER WIRE, THE PLASTIC KINKS WHEN TRYING TO PUSH THROUGH INCISION SITE. TO COMPLETE THE PROCEDURE, THE TRACT WAS DILATED THEN THE DEVICE WAS ADVANCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064210 ↗
• InjuryJan 13, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN ADVANCING THE PEG TUBE OVER WIRE, THE PLASTIC KINKS WHEN TRYING TO PUSH THROUGH INCISION SITE. TO COMPLETE THE PROCEDURE, THE TRACT WAS DILATED THEN THE DEVICE WAS ADVANCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064207 ↗
• InjuryJan 9, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN ADVANCING THE PEG TUBE OVER WIRE, THE PLASTIC KINKS WHEN TRYING TO PUSH THROUGH INCISION SITE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE INSERTION TUBE DEVICE WITH SEVERAL KINKS. TO COMPLETE THE PROCEDURE, THE TRACT WAS DILATED THEN THE DEVICE WAS ADVANCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027614 ↗
• MalfunctionFeb 20, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHODS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST PEG TUBE CORKSCREWED AT THE BOTTOM AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE TUBE ALONG THE WIRE AND INTO THE PATIENT. THE 2ND PEG TUBE BROKE IN HALF WHEN THE PHYSICIAN WAS PULLING IT THROUGH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE STANDARD PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422547 ↗
• MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHODS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST PEG TUBE CORKSCREWED AT THE BOTTOM AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE TUBE ALONG THE WIRE AND INTO THE PATIENT. THE 2ND PEG TUBE BROKE IN HALF WHEN THE PHYSICIAN WAS PULLING IT THROUGH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE STANDARD PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417350 ↗
• MalfunctionJul 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING PREPARATION, THE PEG TUBE DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944176 ↗
• InjuryJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC IN THE GASTRIC WALL AND STOMA INCISION. THE PROCEDURE WAS NOT COMPLETED, AND PATIENT WAS SENT FOR EXPLORATORY LAPAROTOMY SURGERY. IT WAS REPORTED THAT PATIENT WAS ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE AND WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359849 ↗