EndoVive™ One Step Button™ M00568530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729149941), received between Apr 18, 2019 and Oct 1, 2020 — classified as 3 injuries, 1 malfunction.

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.

• InjuryOct 1, 2020Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT'S STOMACH. REPORTEDLY, THE DETACHED PORTION WAS REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10613128 ↗
• InjuryJul 6, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A FEEDING TUBE REPLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2020, PATIENT WAS HOSPITALIZED DUE TO REFLUX OF STOMACH CONTENTS AND NUTRIENTS THAT OCCURRED. THE PHYSICIAN ATTRIBUTES THE REFLUX TO THE MALFUNCTION OF THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW ENDOVIVE ONE STEP BUTTON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10232541 ↗
• MalfunctionFeb 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PLACING THE BUTTON THE BOLSTER WENT THROUGH THE STOMA SITE AND OUTSIDE THE PATIENT WITHOUT ANY RESISTANCE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON (DIFFERENT SIZE). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744531 ↗
• InjuryApr 18, 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 GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER CONNECTING THE INSERTION WIRE TO THE LOOP ON THE ENDOVIVE ONE STEP BUTTON, AS THE CATHETER WAS BEING PULLED OUT FROM THE ABDOMEN REPORTEDLY, THE TUBE BUTTON GOT BROKEN. THE PHYSICIAN TRIED TO PLACE ONLY THE REMAINING BUTTON PART HOWEVER IT DETACHED IN THE STOMACH. THE DETACHED PORTION WAS RETRIEVED WITH THE ENDOSCOPE. 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 8528365 ↗