EndoVive Standard PEG Kit M00568240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729748700), received between Dec 20, 2019 and Jan 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 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 (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PEG TUBE CAME APART DURING PLACEMENT. THE PHYSICIAN WAS ABLE TO GRASP THE PLASTIC TIP AND PULL THE TUBING THROUGH. A PHOTO OF THE DEVICE 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 THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280405 ↗
• MalfunctionOct 21, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. POST PROCEDURE, THE NURSE REPORTED THE PEG TUBE CAME OUT OF THE PATIENT. THE INTERNAL BOLSTER APPEARED TO HAVE DETACHED. A 20FRENCH FOLEY CATHETER WAS SECURED IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 25, 2022: AS PER BSC INVESTIGATION TEAM, THE DEVICE THAT WAS RETURNED IS NON-BSC BALLOON DEVICE (AVANOS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650100 ↗
• MalfunctionDec 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LOOP WIRE AT THE END OF THE PEG TUBE BROKE. REPORTEDLY, NOTHING DETACHED INSIDE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 9504293 ↗