Captivator EMR M00561610Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729842699), received between Feb 12, 2020 and Jun 22, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR EMR SNARE WAS USED FOR A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580052 ↗
• MalfunctionOct 19, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SUTURE THREAD WAS BROKEN, AND THE BANDS COULD NOT BE RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR EMR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632414 ↗
• InjuryMar 1, 2022Use of Device Problem; Suction Problem; Use of Device Problem; Suction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED DURING A ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2022. WHEN THE DEVICE WAS OPENED THE BLUE CAP WAS DROPPED/LOST SO THE BLUE CAP WAS MISSING. THE TECHNICIAN USED THEIR FINGER TO COMPLETE SUCTION LOOP INSTEAD. THE DEVICE WAS SUCCESSFULLY USED IN THE ANTRUM. WHEN USED IN THE FUNDUS, THE BAND CAPTURED MUSCULARIS DUE TO TOO MUCH SUCTION AND THE BAND WAS DEPLOYED OVER THE WHOLE WALL AND WAS NOT REALIZED UNTIL AFTER IT WAS CUT, AND A PERFORATION OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-BSC CLIP DEVICE. THE PATIENT OUTCOME WAS REPORTED TO BE FULLY RECOVERED. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: Perforation

  MAUDE report 13639856 ↗
• MalfunctionJun 16, 2021Premature Activation; Appropriate Device Problem Term/Code Not Available; Premature Activation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, IT WAS NOTED THAT TWO BANDS DEPLOYED WITH JUST ONE TURN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. REPORTEDLY, THE PATIENT WAS ALREADY SEDATED WHEN THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008939 ↗
• MalfunctionMay 4, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED IN THE STOMACH ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE SUTURE WAS FOUND CUT AND BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020800 ↗
• InjuryFeb 12, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE BROKE IN THE WORKING CHANNEL OF THE SCOPE. REPORTEDLY, THE BANDS FELL OFF THE DEVICE INSIDE OF THE PATIENT. TWO OF THE BANDS WERE RETRIEVED FROM THE BACK OF THE THROAT USING FORCEPS, AND THREE BANDS MIGRATED INTO THE STOMACH. THE SIXTH BAND COULD NOT BE LOCATED SO A BRONCHOSCOPE WAS USED TO CHECK THE LUNGS. THE BRONCHOSCOPY CONFIRMED THAT THE SIXTH BAND DID NOT MIGRATE TO THE PATIENT'S LUNGS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 9699203 ↗