CAPTIVATOR II M00561230Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 08714729861324), received between Nov 17, 2016 and Sep 3, 2026 — classified as 83 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (38 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 19, 2021Open, Classified

   Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

   Z-1169-2021 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599423 ↗
• MalfunctionJul 20, 2026Electrical /Electronic Property Problem; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882156 ↗
• MalfunctionJul 8, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARE WAS USED IN THE STOMACH DURING A POLYPECTOMY PROCEDURE FOR THE REMOVAL OF AN 8 MM POLYP, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN CAPTURED THE POLYP, HE PUSHED THE PEDAL TO HOT POLYPECTOMY, HOWEVER, NOTHING HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751095 ↗
• MalfunctionJul 7, 2026Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED FOR A COLD POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO CUT EASILY THE TARGET POLYP. PROCEDURE WAS COMPLETED WITH HEAT ADDED TO THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738468 ↗
• MalfunctionJul 1, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE INTESTINAL TRACT FOR AN ESOPHAGEAL ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO DELIVER ENERGY. 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 25682434 ↗
• MalfunctionJun 30, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO COLD CUT A PEDUNCULATED POLYP. AFTER THAT, THE DEVICE WAS UNABLE TO DELIVER HEAT WHEN SOFT COAGULATION WAS ATTEMPTED TO CAUTERIZE THE POLYP SITE. AS A RESULT, CLIPS WERE PLACED TO STOP THE BLEEDING AT POLYP SITE. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25673471 ↗
• MalfunctionJun 4, 2026Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP WITH HEAT, BUT THE SNARE WAS UNABLE TO CUT. ALL THE LEADS WERE REPLACED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25388541 ↗
• MalfunctionMay 11, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS INTENDED TO BE USE IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE NURSE INDICATED THE SNARE WAS NOT ABLE TO CONNECT TO HEAT, EVEN AFTER RESTATING THE GENERATOR DEVICE WOULD NOT CONNECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140111 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE BROKE. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS PERTAINS TO DEVICE ONE OF TWO USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876097 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE BROKE. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS PERTAINS TO DEVICE TWO OF TWO USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876096 ↗
• MalfunctionApr 7, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800011 ↗
• MalfunctionJan 8, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED FOR A POLYP IN THE COLON DURING A COLORECTAL POLYP RESECTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004900 ↗
• MalfunctionNov 24, 2025Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, PUNCTURE AND ABLATION HAD OCCURRED DUE TO ENERGIZATION FAILURE. ENERGIZATION WAS POSSIBLE HALFWAY THROUGH; HOWEVER, IT COULD NO LONGER BE PERFORMED DURING THE FINAL POLYP RESECTION. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637416 ↗
• MalfunctionNov 14, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTICED THAT THERE WAS ENERGIZATION FAILURE IN CAPTIVATOR II SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553810 ↗
• MalfunctionOct 30, 2025Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON TO REMOVE AN 8-MM POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WOULD NOT HEAT UP. THERE WAS NO CAUTERY TO CUT THROUGH THE POLYP. THE MACHINE WAS CHECKED, IT WAS ON AND EVERYTHING WAS CONNECTED PROPERLY. THERE WERE NO VISIBLE PROBLEM 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423972 ↗
• MalfunctionSep 23, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE OF EVENT. DURING THE PROCEDURE, THE SNARE WOULD NOT PASS DOWN THE SCOPE AS THEY TRIED COUPLE OF TIMES. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125286 ↗
• MalfunctionSep 3, 2025Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR II SNARE WAS USED TO REMOVE A POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD, HOWEVER, IT WOULD NOT EFFECTIVELY CUT, AND COAGULATION WAS NOT WORKING. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952554 ↗
• MalfunctionAug 29, 2025Failure 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 II SNARE WAS USED IN THE TRANSVERSE COLON TO REMOVE A LESS THAN 1CM SESSILE POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS PASSED THROUGH THE SCOPE AND WAS SECURELY CONNECTED TO THE ACTIVE CABLE. HOWEVER, WHEN CAUTERY WAS ENGAGED, THE SNARE WAS UNABLE TO CUT, AND COAGULATION WOULD NOT WORK. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926497 ↗
• MalfunctionAug 14, 2025Failure to Cut; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE INTESTINE TO REMOVE A POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE HANDLE WAS NOT SMOOTH AND THERE WAS A PROBLEM WITH THE DEPLOYMENT. THE SNARE COULD BE EXTENDED WITH FORCES APPLIED, BUT NOT SMOOTH AND COULD NOT REMOVE THE POLYP ACCURATELY. 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 22806059 ↗
• MalfunctionJul 16, 2025Difficult to Open or Close; Ejection Problem

  FROM STAFF: SNARE DISPOSABLE PRODUCT MALFUNCTIONED DURING PROCEDURE. PATIENT WAS HERE FOR ENDOSCOPY PROCEDURE THAT REQUIRED A SNARE. THE SNARE DID NOT OPEN COMPLETELY WHEN DEPLOYED. SNARE WAS SEQUESTERED AND A NEW SNARE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519302 ↗
• MalfunctionJul 15, 2025Difficult to Open or Close; Activation Problem

  FROM STAFF: PATIENT WAS HAVING AN ENDOSCOPY PROCEDURE REQUIRING A SNARE INSTRUMENT. SNARE INSTRUMENT WAS OPENED AND READIED TO DEPLOY. WHEN THE SNARE WAS DEPLOYED IT WOULD NOT OPEN COMPLETELY. SNARE WAS REMOVED AND A NEW SNARE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22509055 ↗
• MalfunctionMay 29, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE STOMACH DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS INSERTED THROUGH THE SCOPE CHANNEL AND OPENED COMPLETELY BUT WOULD NOT CLOSE AROUND THE POLYP AT ALL. THEY HAD TO COMPLETELY REMOVE THE SNARE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR SNARE 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR- REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE CAUTERY PIN WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104622 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II 15 MM ROUNDED STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE WAS DISCONNECTED FROM THE HANDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MAY 14, 2025: THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II 15 MM ROUNDED STIFF SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969451 ↗
• MalfunctionFeb 5, 2025Failure to Deliver Energy; Mechanical Problem; Failure to Deliver Energy; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW WAS USED FOR A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS AN ONGOING ISSUE WITH THE SNARE, PARTICULARLY WITH FULLY EXTENDING IT FROM THE SHEATH. THEY ALSO MENTIONED THAT THE CAUTERY WAS NOT ABLE TO WORK CONSISTENTLY WITH THE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312697 ↗
• MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-15 MM ROUND STIFF SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE FOR COLORECTAL POLYPS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS REPORTED THAT THE METAL FITTINGS ON THE ACTIVE CORD AND THE GOLD METAL FITTINGS HAD COME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II-15 MM ROUND STIFF SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871322 ↗