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EndoVive One Step Button M00563030Recalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729284161), received between Dec 1, 2016 and May 8, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 8, 2018Detachment Of Device Component; Detachment Of Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PULL WIRE DETACHED FROM THE ONE STEP BUTTON TUBE AND FELL OFF IN THE STOMACH. THE DETACHED PORTION WAS RETRIEVED USING A SNARE. REPORTEDLY, PATIENT WENT TO SURGERY TO HAVE DIFFERENT FEEDING TUBE PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7494195 ↗
  • InjuryDec 1, 2016Detachment Of Device Component; Detachment Of Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE TUBE WAS BEING PULLED TO THE STOMA SITE, THE CATHETER SHEATH BROKE INSIDE THE PATIENT. EVERYTHING WAS RETRIEVED AND NO PARTS OF THE DEVICE WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT. 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 NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6137712 ↗

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.