CAPTIVATOR M00562390Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729747925), received between Sep 14, 2017 and Dec 3, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ELECTRICAL CUTTING CONNECTOR ON THE SNARE HANDLE WAS DETACHED, SO THE ELECTRICAL CUTTING FUNCTION COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836408 ↗
• MalfunctionSep 6, 2023Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LG OVAL THIN WIRE FLEX SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023 DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO GENERATE ELECTRICITY AND COULD NOT EFFECTIVELY REMOVE THE POLYPS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR LG OVAL THIN WIRE FLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689287 ↗
• MalfunctionAug 15, 2023Failure to Cut; Positioning Problem; Failure to Cut; Positioning Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-04401, 3005099803-2023-04402, FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN ACCURATELY POSITIONING THE SNARE LOOP AROUND A ONE CENTIMETER POLYP IN THE TRANSVERSE AND SIGMOID COLON. AS A RESULT, THE SNARE WAS UNABLE TO FULLY CUT THE POLYP, LEADING TO AN INCOMPLETE INCISION. HOWEVER, THERE WAS NO PERFORATION. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17548123 ↗
• MalfunctionJun 30, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LG OVAL THIN WIRE FLEX SNARE WAS USED TO REMOVE INTESTINAL POLYPS IN THE INTESTINAL TRACT DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WAS SECURELY ATTACHED TO THE ACTIVE CORD BUT THERE WAS NO RESPONSE TO ELECTRIC CUTTING. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876142 ↗
• InjuryAug 28, 2020Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-03571 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LG OVAL THIN WIRE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS TESTED OUTSIDE THE PATIENT AND IT WORKED FINE. WHILE USED INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO ACHIEVE CAUTERY AND WAS UNSUCCESSFUL IN RESECTING THE TARGET POLYP. A SECOND DEVICE WAS USED, HOWEVER, IT ENCOUNTERED THE SAME ISSUE. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND HEMATOMA. SINCE THE MASS COULD NOT BE RESECTED AT THE OUTPATIENT CENTER, THE PATIENT WAS REFERRED TO THE HOSPITAL FOR SURGERY TO REMOVE THE MASS AT A LATER DATE. THE BLEEDING WAS NOT THE REASON FOR THE REFERRAL. THERE WERE NO OTHER INTERVENTIONS PERFORMED OR TREATMENT PROVIDED FOR THE PATIENT. IT IS UNKNOWN IF THE SURGERY TO REMOVE THE MASS HAS BEEN PERFORMED. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE OKAY.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10466424 ↗
• InjuryAug 28, 2020Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-03571 AND 3005099803-2020-03572 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LG OVAL THIN WIRE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS TESTED OUTSIDE THE PATIENT AND IT WORKED FINE. WHILE USED INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO ACHIEVE CAUTERY AND WAS UNSUCCESSFUL IN RESECTING THE TARGET POLYP. A SECOND DEVICE WAS USED, HOWEVER, IT ENCOUNTERED THE SAME ISSUE. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND HEMATOMA. SINCE THE MASS COULD NOT BE RESECTED AT THE OUTPATIENT CENTER, THE PATIENT WAS REFERRED TO THE HOSPITAL FOR SURGERY TO REMOVE THE MASS AT A LATER DATE. THE BLEEDING WAS NOT THE REASON FOR THE REFERRAL. THERE WERE NO OTHER INTERVENTIONS PERFORMED OR TREATMENT PROVIDED FOR THE PATIENT. IT IS UNKNOWN IF THE SURGERY TO REMOVE THE MASS HAS BEEN PERFORMED. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE OKAY.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10466385 ↗
• MalfunctionJul 30, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LG OVAL THIN WIRE FLEX SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT CUT THROUGH THE TISSUE AS GOOD AS IT USED TO. REPORTEDLY, THE SNARE WAS USED FOR MULTIPLE POLYPS WITH UNKNOWN SIZES. THERE WERE NO OTHER ISSUES NOTED WITH THIS DEVICE. THIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343671 ↗
• MalfunctionFeb 1, 2019Failure to Deliver Energy; Entrapment of Device; Failure to Deliver Energy; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LG OVAL THIN WIRE FLEX SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO DELIVER ENERGY AND THE SNARE LOOP BECAME STUCK IN THE MUCOSA. REPORTEDLY, THE SNARE LOOP HAD TO BE CUT TO REMOVE THE DEVICE AND IT WAS UNKNOWN WHAT DEVICE WAS USED TO REMOVE THE SNARE LOOP. REPORTEDLY, THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PIN AND THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297246 ↗
• MalfunctionJul 19, 2018Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP FAILED TO CUT THE TARGET POLYP AND WAS UNABLE TO RETRACT INSIDE THE CATHETER. IT WAS REPORTED THAT CAUTERY WAS USED TO CUT THE POLYP SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704723 ↗
• InjurySep 14, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP WAS DETACHED INSIDE THE PATIENT. THE DEVICE WAS RETRIEVED SUCCESSFULLY WITH A NET AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6864466 ↗