EndoVive One Step ButtonRecalls & reported problems across all models
Boston Scientific Corporation · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 9 models of EndoVive One Step Button by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Jun 4, 2025 — classified as 13 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EndoVive One Step Button problems
Device problems
- Detachment of Device or Device Component17
- Adverse Event Without Identified Device or Use Problem6
- Detachment Of Device Component4
- Break2
- Device Dislodged or Dislocated2
- Difficult to Advance2
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient20
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient3
- Hemorrhage/Blood Loss/Bleeding2
- No Code Available1
EndoVive One Step Button models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EndoVive™ One Step Button™ M00568520TUBE, GASTRO-ENTEROSTOMY13 reports
- EndoVive™ One Step Button™ M00568530TUBE, GASTRO-ENTEROSTOMY4 reports
- EndoVive™ One Step Button™ M00568510TUBE, GASTRO-ENTEROSTOMY4 reports
- EndoVive One Step Button M00563040TUBE, GASTRO-ENTEROSTOMY2 reports
- EndoVive One Step Button M00563030TUBE, GASTRO-ENTEROSTOMY2 reports
- EndoVive™ One Step Button™ M00568470TUBE, GASTRO-ENTEROSTOMY1 report
- EndoVive™ One Step Button™ M00568500TUBE, GASTRO-ENTEROSTOMY1 report
- EndoVive One Step Button M00563150TUBE, GASTRO-ENTEROSTOMY1 report
- EndoVive™ One Step Button™ M00509710Gastrointestinal Tubes with Enteral Specific Connectors1 report
Recent EndoVive One Step Button adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 4, 2025Detachment 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 THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) PROCEDURE TO TREAT MALNUTRITION PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLS THE PEG TUBE THROUGH THE STOMACH WALL THE PULL TUBE BROKE AT THE CONNECTION POINT OF THE TUBE AND THE IMPLANT. IT WAS REPORTED THAT THE IMPLANT FELL BACK INTO THE STOMACH AND HAD TO BE RETRIEVED WITH THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE ONE STEP BUTTON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22146644 ↗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 ↗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 ↗MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON PULL METHOD WAS USED DURING A GASTROSTOMY PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, WHEN ENDOVIVE ONE STEP WAS PULLED OUT THE TUBE SEPARATED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE ONE STEP BUTTON PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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
MAUDE report 11922565 ↗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 ↗MalfunctionNov 12, 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 PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ONE STEP BUTTON LOOP WIRE WAS PULLED, THE TIP SEPARATED. THE DEVICE WAS REMOVED AND 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 10829124 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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