EndoVive Safety PEG Kit M00509030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729880448), received between Aug 3, 2022 and Mar 17, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A PEG TUBE WAS INSERTED OVER THE GUIDEWIRE THROUGH THE MOUTH AND ADVANCED UNTIL THE END OF THE TUBE WAS VISIBLE AT THE PUNCTURE SITE ON THE ANTERIOR ABDOMINAL WALL. TRACTION WAS THEN APPLIED TO FACILITATE THE TUBE PASSAGE THROUGH THE ABDOMINAL WALL. WHEN PASSING THE CONNECTOR THROUGH THE ABDOMINAL WALL, THE TWO PORTIONS OF THE TUBE BECAME SEPARATED, ONE PART INSIDE THE PATIENT AND THE OTHER OUTSIDE THE PATIENT. THE GUIDEWIRE WAS IN PLACE ALLOWING BOTH THE EXTERNAL AND INTERNAL PORTIONS TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627926 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE PLACING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) DEVICE, IT SEPARATED AT THE TRANSITION JOINT. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE TRANSITION JOINT BETWEEN THE PEG TUBE AND THE INTRODUCER DILATOR WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY 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 20559676 ↗
• MalfunctionOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SILICONE PLASTIC JUNCTION WAS DETACHED. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE TRANSITION JOINT BETWEEN PEG TUBE AND INTRODUCER DILATOR WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY 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 20545565 ↗
• MalfunctionOct 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PEG TUBE DISASSOCIATED AT THE TRANSITION ZONE. A SECOND PEG KIT WAS OPENED AND ATTEMPTED TO BE USED BUT, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY 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 20519058 ↗
• MalfunctionOct 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PEG TUBE DISASSOCIATED AT THE TRANSITION ZONE. A SECOND PEG KIT WAS OPENED AND ATTEMPTED TO BE USED BUT, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY 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 20518173 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PEG TUBE DETACHED AT THE TRANSITION ZONE WHERE THE HARD PLASTIC MEETS THE SILICONE TUBING. THE PROCEDURE WAS COMPLETED WITH A SECOND ENDOVIVE SAFETY 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 20385302 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PEG TUBE DETACHED AT THE TRANSITION ZONE WHERE THE HARD PLASTIC MEETS THE SILICONE TUBING. THE PROCEDURE WAS COMPLETED WITH A SECOND ENDOVIVE SAFETY 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 20385183 ↗
• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN IT WAS ATTEMPTED TO PULL THE INTRODUCER PART OF THE PUSH TYPE PEG IT SEPARATES OFF OF THE SILICONE TUBE. A PHOTO WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE TRANSITION JOINT BETWEEN THE PEG TUBE AND THE INTRODUCER DILATOR WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY 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 20173727 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED IN THE GASTRIC DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PEG TUBE BROKE UPON PULLING. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY 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 19940775 ↗
• MalfunctionFeb 1, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623510 ↗
• InjuryJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE PEG TUBE TORE APART. REPORTEDLY, AIR LEAKED INTO THE PERITONEUM REQUIRING AN ANGIOCATH TO BE INSERTED TO RELEASE THAT AIR. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040235 ↗
• InjuryApr 28, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2023. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE PEG TUBE BROKE OFF. THE DETACHED PORTION WAS SURGICALLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PUSH METHOD. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831990 ↗
• InjuryAug 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE PEG TUBE DETACHED INSIDE THE STOMA SITE. THEY WERE ABLE TO RETRIEVE THE TUBE. THE PROCEDURE WAS COMPLETE A NEW ENDOVIVE SAFETY 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 15160528 ↗