EndoVive™ One Step Button™ M00568510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729151081), received between Jan 7, 2019 and Jul 6, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONESTEP BUTTON WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. POST PROCEDURE, THE RIGHT ANGLE FEEDING PORT WAS OBSTRUCTED. THE DEVICE WAS REPLACED WITH A NEW RIGHT ANGLE FEEDING TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121777 ↗
• MalfunctionSep 10, 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 IN A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: ONE STEP BUTTON DELIVERY SYSTEM WAS BROKEN INTO TWO PIECES AND STRETCHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10513625 ↗
• InjuryJun 20, 2019Detachment 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 PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS BEING PULLED INSIDE THE BODY, SEVERE RESISTANCE WAS FELT. FORCE WAS APPLIED SLOWLY; HOWEVER, THE SHEATH WITH THE BUTTON INSIDE DETACHED FROM THE TUBE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8715975 ↗
• MalfunctionJan 7, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON PULL METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PULLING THE DEVICE THROUGH THE INCISION SITE, NORMALLY IT WOULD GET CAUGHT DUE TO THE BUTTON; HOWEVER, WHEN THEY PULLED THIS DEVICE, THERE WAS NO RESISTANCE MET AND IT WAS COMPLETELY TAKEN OUT FROM THE PATIENT'S BODY AS ONE UNIT. IT WAS ALSO NOTICED THAT THE SITE HAD BLEEDING BUT WAS RESOLVED THROUGH CLIPPING. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. THERE WERE NO REPORTED PATIENT COMPLICATIONS DUE TO THIS EVENT AND THERE WAS NO ISSUE OBSERVED WITH THE PATIENT'S CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8221693 ↗