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EndoVive One Step Button M00563150Recalls & reported problems

Boston Scientific Corporation · Low Profile Percutaneous Endoscopic Gastrostomy Kit · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729284277), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PEG TUBE DETACHED WHEN IT WAS BEING PULLED THROUGH THE STOMA SITE. THE DETACHED PORTION WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON. 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 9655602 ↗

Other TUBE, GASTRO-ENTEROSTOMY devices

All TUBE, GASTRO-ENTEROSTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.