EndoVive Standard PEG Kit M00568250Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729748717), received between Nov 15, 2017 and Jul 10, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Detachment 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 ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. UPON INSERTION OF THE PEG TUBE, THE PLASTIC PART OF THE PEG TUBE/DRAIN CAME APART INTO TWO PIECES OUTSIDE OF THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. DURING THE PROCEDURE, PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE WAS PLACED TO THE PATIENT. UPON INSERTION, THE PLASTIC PART OF THE PEG TUBE/DRAIN CAME APART INTO TWO PIECES OUTSIDE OF THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714929 ↗
• MalfunctionApr 9, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT ADVANCE THROUGH THE SECTION OF PEG TUBE. 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 19072734 ↗
• MalfunctionJun 21, 2023Detachment 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 WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT ON (B)(6) 2023. DURING THE PROCEDURE, THE PEG TUBE CAME APART, CAUSING IT TO BE SEPARATED INSIDE AND OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN STILL HAD THE DEVICE IN HAND AND WAS ABLE TO PUT IT BACK TOGETHER WITHOUT CHANGING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL ENDIVE STANDARD PEG KIT PUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170961 ↗
• InjuryJul 12, 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, WHEN PULLING THE PEG TUBE THROUGH THE STOMACH WALL, IT DETACHED BEFORE COMING THROUGH THE STOMA. THE DETACHED PORTION WAS RETRIEVED USING A RAT TOOTH GRASPER. 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 14989024 ↗
• MalfunctionJan 30, 2019Detachment 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 (EGD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLED THE PEG TUBE THROUGH THE STOMA, THE OTHER END OF THE PEG TUBE DETACHED IN THE MOUTH OF THE PATIENT. REPORTEDLY, THE PHYSICIAN REMOVED THE DETACHED PORTION BY HAND. 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 Consequences Or Impact To Patient

  MAUDE report 8290972 ↗
• MalfunctionApr 17, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THEY ATTEMPTED TO GRAB THE WIRE USING A RETRIEVAL SNARE, THE LOOP WIRE ON THE END OF THE SNARE WAS BROKEN. NOTHING DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435761 ↗
• MalfunctionNov 15, 2017Detachment Of Device Component; Detachment Of 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 PERFORMED ON (B)(6) 2017.   ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PEG TUBE WAS PULLED OUT OF THE STOMA SITE, IT DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC. THE PHYSICIAN WAS ABLE TO GRAB THE TUBE AND PULLED IT THROUGH. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE.   THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033151 ↗
• MalfunctionNov 15, 2017Detachment Of Device Component; Detachment Of 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 PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PEG TUBE WAS PULLED OUT OF THE STOMA SITE, IT DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7032997 ↗