EndoVive Standard PEG Kit M00509040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729880462), received between May 7, 2022 and Nov 17, 2025 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryNov 17, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SURGEON COULD NOT GET THE DEVICE TO SLIDE OR OPERATE AT ALL. THE PEG ITSELF WAS NOT WORKING PROPERLY CAUSING THE SURGEON TO REQUEST A NEW ONE. ADDITIONAL CLARIFICATION REGARDING THE NATURE OF THE SERIOUS INJURY OR THE TYPE OF REQUIRED INTERVENTION WAS NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 23566442 ↗
• MalfunctionMay 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS INSPECTED ON MAY 6, 2025. UPON INSPECTION, IT WAS REPORTED THAT A HAIR WAS INSIDE THE UNOPENED, STERILE DEVICE POUCH. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWS A HAIR-LIKE PARTICLE ON THE TUBING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106471 ↗
• InjuryMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TUBE BROKE WHILE BEING PULLED THROUGH THE ANTERIOR ABDOMINAL WALL. PART OF THE TUBE WAS LEFT IN THE PATIENT'S STOMACH. A LAPAROTOMY WAS PERFORMED TO RETRIEVE THE BROKEN TUBE AND PLACED A GASTROSTOMY TUBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969567 ↗
• InjuryOct 2, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, MODERATE SEDATION WAS APPLIED TO THE PATIENT. IT WAS OBSERVED THAT THE PULL WIRE BROKE OFF AS IT WAS PULLED THROUGH THE INCISION. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE, AND THE PEG TUBE REMAINED INSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED TO A SHORT-TERM ACUTE CARE (STAC) HOSPITAL AND THE SAME PHYSICIAN COMPLETED THE PROCEDURE UNDER GENERAL ANESTHESIA. THE PEG TUBE WAS REMOVED AND REPLACED WITH A NEW PEG TUBE. IT WAS REPORTED THAT THE PATIENT WAS OKAY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ENDOVIVE STANDARD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352350 ↗
• MalfunctionSep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 EXACT PROCEDURE DATE WAS UNKNOWN. POST PROCEDURE, THE PEG TUBE THAT THE PHYSICIAN PLACED WAS DISLODGED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325140 ↗
• DeathMay 7, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACEMENT PROCEDURE (B)(6) 2021. THE PATIENT HAD AN INITIAL PEG TUBE PLACED ONE YEAR EARLIER AFTER BEING INJURED IN A MVC (MOTOR VEHICLE COLLISION). A SITTER IS REQUIRED TO PREVENT TUBE/IV MANUAL REMOVAL BY PATIENT WHO WAS CONFUSED. ON (B)(6) 2021, PROPER PLACEMENT OF TUBE WAS CONFIRMED VIA CAT (COMPUTERIZED AXIAL TOMOGRAPHY) SCAN AND PATIENT WAS TRANSFERRED FROM MEDICAL UNIT TO ICU (INTENSIVE CARE UNIT). PATIENT LATER DEVELOPED SYMPTOMS OF AN ACUTE ABDOMEN. DISTENDED ABDOMEN AND HYPOTENSION WERE NOTED. ON (B)(6) 2021, WHEN AN EXPLORATORY LAPAROTOMY WAS DONE TO REMOVE TUBE AND CLEAN OUT ABDOMEN. A GROSSLY ENLARGED LIVER WAS NOTED TO HAVE OVERLAPPED THE STOMACH, AND PEG TUBE HAD TRACT THROUGH LEFT LOBE OF LIVER. THE PEG WAS FOUND TO HAVE DISLODGED FROM STOMACH, RESULTING IN PERITONITIS. THE PEG TUBE WAS NOT RETAINED, HOWEVER THERE WAS NO REPORT FROM THE OPERATING ROOM TEAM WHO REMOVED THE PEG THAT THERE WERE ANY DEFECTS OR MISSING PARTS UPON EXTRACTION. NO EVIDENCE OF ANY DEVICE DEFECT. CONTINUED HYPOTENSION WAS NOTED POST OPERATIVE D

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Peritonitis; Respiratory Arrest; Respiratory Failure; Sepsis

  MAUDE report 14317703 ↗