EndoVive™ One Step Button™ M00568520Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729149231), received between Aug 29, 2018 and Jan 10, 2023 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON PULL KIT WAS USED DURING A GASTROSTOMY PROCEDURE. IT WAS REPORTED THAT THERE WAS A CASE IN WHICH THE LOOP ATTACHED TO THE TIP OF THIS DEVICE WAS TORN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130025 ↗
• MalfunctionNov 25, 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 (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ONE STEP BUTTON WAS BEING PULLED THE TUBING SEPARATED INSIDE THE PATIENT'S MOUTH. 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 10904632 ↗
• MalfunctionNov 16, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON (OSB) USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BUTTON PORTION OF THE ONE STEP BUTTON TUBE BECAME STUCK IN THE PATIENT'S PHARYNX AND CAUSED A MINOR HEMORRHAGE WHICH WAS REPORTED TO HAVE STOPPED BY THE END OF THE PROCEDURE. THERE WAS NO TREATMENT ADMINISTERED. IN ADDITION, THERE WAS STRONG RESISTANCE WHEN PULLING OUT THE OSB FROM THE STOMA SITE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10844445 ↗
• InjuryOct 19, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE ONE STEP BUTTON WAS PASSED THROUGH THE PATIENT, THE CATHETER WAS TORN AND SEPARATED. 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 10695557 ↗
• MalfunctionOct 5, 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 HIGH DIGESTIVE VIDEO ENDOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BUTTON DETACHED FROM THE SHEATH PRIOR TO BEING RELEASED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10627429 ↗
• InjuryAug 5, 2020Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ONE STEP BUTTON WAS PULLED FROM THE ORAL CAVITY INTO THE STOMACH, THE BUTTON CAME OUT OF THE SHEATH EARLIER AND WAS DISLODGED. REPORTEDLY, THE PROCEDURE WAS CANCELLED AND RESCHEDULED ON (B)(6) 2020 USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369054 ↗
• MalfunctionJul 22, 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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ONE STEP BUTTON SHEATH DETACHED WHEN THE PHYSICIAN WAS PULLING IT THROUGH THE STOMA SITE. REPORTEDLY, THE BUTTON PORTION WAS ABLE TO BE GRASPED BEFORE IT FEEL INTO THE PATIENT'S STOMACH. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310923 ↗
• MalfunctionMay 28, 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 FEEDING TUBE REPLACEMENT PROCEDURE. THE PROCEDURE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN RELEASED THE ONE STEP BUTTON, IT BROKE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10097297 ↗
• InjuryAug 27, 2019Detachment 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 KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS PULLED FROM THE INSIDE OUT OF THE STOMA, THE CATHETER HAD DETACHED. REPORTEDLY, THERE WAS NO RESISTANCE ENCOUNTERED WHEN IT WAS PULLED. THE PEG TUBE DETACHED INSIDE PATIENT AND THE DETACHED PORTION WAS RETRIEVED VIA ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON 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 8935075 ↗
• InjuryAug 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 (10 DAYS POST PROCEDURE), THE PATIENT WAS HOSPITALIZED AS THE FEEDING TUBE DISLODGED INSIDE THE BODY AND REACHED THE SMALL INTESTINES BEYOND TREITZ' LIGAMENT. THE DEVICE WAS REMOVED ENDOSCOPICALLY ON THE SAME DAY USING AN ERCP GUIDEWIRE, BASKET CATHETER, AND SNARE. THE PROCEDURE WAS COMPLETED PLACING A DIFFERENT GASTROSTOMY TUBE DEVICE OF DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892829 ↗
• InjuryApr 2, 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 INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TUBE SEPARATED WHILE IT WAS BEING PULLED OUT. SINCE THE STOMACH WALL WAS FIXED, THE BUTTON PART WAS RETRIEVED USING A SNARE AND WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (NON BSC DEVICE). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8473216 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187799 ↗
• MalfunctionAug 29, 2018Unexpected Therapeutic Results; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration; Unexpected Therapeutic Results; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED IN PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PASSING THE ONE STEP BUTTON, IT HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7828282 ↗