EndoVive Safety PEG Kit M00566480Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729748403), received between Nov 11, 2016 and Jul 15, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryJul 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING AN INITIAL PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, IT WAS INCREASINGLY DIFFICULT TO REMOVE THE BUMPER. IT WAS REPORTED THAT THE PHYSICIAN HAD TO SCHEDULE THE PATIENT FOR EGD (ESOPHAGOGASTRODUODENOSCOPY) TO REMOVE THE PEG TUBE INTERNALLY BECAUSE IT WAS DIFFICULT TO REMOVE BY HAND VIA TRACTION. IT WAS ALSO REPORTED THAT LOCAL ANESTHESIA WAS GIVEN DURING TRACTION REMOVAL ATTEMPTS AND THE EGD REMOVAL WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509282 ↗
• InjuryJul 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING AN INITIAL PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, IT WAS INCREASINGLY DIFFICULT TO REMOVE THE BUMPER. IT WAS REPORTED THAT THE PHYSICIAN HAD TO SCHEDULE THE PATIENT FOR EGD (ESOPHAGOGASTRODUODENOSCOPY) TO REMOVE THE PEG TUBE INTERNALLY BECAUSE IT WAS DIFFICULT TO REMOVE BY HAND VIA TRACTION. IT WAS ALSO REPORTED THAT LOCAL ANESTHESIA WAS GIVEN DURING TRACTION REMOVAL ATTEMPTS AND THE EGD REMOVAL WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509279 ↗
• MalfunctionJan 18, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE FEEDING PORT OF THE DEVICE WAS CLOGGED. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 18536283 ↗
• InjuryOct 19, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY AND ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED WHEN THE TROCAR WAS PLACED INTO THE PATIENT THE BLUE PART THAT HOLDS THE CANNULA IN PLACE BECAME DISLODGED AND FELL INTO THE PATIENT. THE NEEDLE OF THE TROCAR COULD NOT BE REMOVED. THE PARTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW 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 17967491 ↗
• MalfunctionAug 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936364 ↗
• MalfunctionAug 1, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE¿ SAFETY PEG KIT PULL METHOD WAS USED IN A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, SNARE DEVICE WAS BROKEN IN THE PEG KIT. 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. CORRECTION AS OF AUGUST 10, 2018. IT WAS IN JUNE 2018 WHEN THE SNARE DEVICE WAS FOUND BROKEN IN THE PEG KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739267 ↗
• MalfunctionNov 11, 2016Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THEY PULLED THE PEG TUBE THROUGH THE STOMA SITE, THE PEG TUBE CAME ALL THE WAY FROM THE STOMA SITE OUT OF THE PATIENT. REPORTEDLY, THE INCISION SITE WAS APPROXIMATELY 1.5 CM AND THE BOLSTER WAS NOT ABLE TO ANCHOR WHEN THEY PULLED THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6095528 ↗