CAPTIVATOR II M00561220Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 08714729861294), received between Dec 15, 2016 and Sep 1, 2026 — classified as 15 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (73 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550085 ↗
• MalfunctionJul 20, 2026Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR WAS INTENDED TO BE USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON 22 JUNE 2026.DURING INSERTION, THE SNARE DEVICE HAD POOR ENERGIZATION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882193 ↗
• MalfunctionJul 7, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738448 ↗
• MalfunctionJun 18, 2026Failure to Cut; Difficult to Open or Close

  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 PRESENTED MORE FRICTION THAN USUAL AND COULD NOT MAKE A CLEAN CUT. PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545975 ↗
• MalfunctionJun 17, 2026Failure to Cut; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  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 PRESENTED MORE FRICTION THAN USUAL AND COULD NOT MAKE A CLEAN CUT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536464 ↗
• MalfunctionJun 15, 2026Break; Mechanical Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE WIRE GOT BROKEN IN THE MIDDLE OF THE PROCEDURE. ADDITIONALLY, THE LOOP WAS UNABLE TO OPEN OR CLOSE PROPERLY AROUND POLYP AND CAUSED DIFFICULTY TO POSITION WHEN TIGHTENING. THE PROCEDURE WAS COMPLETE WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE PIN WAS DETACHED. PLEASE SEE H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513163 ↗
• MalfunctionApr 28, 2026Contamination; Adverse Event Without Identified Device or Use Problem

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED, AND A FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH. SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021199 ↗
• MalfunctionApr 24, 2026Failure to Deliver Energy; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE SNARE LOOP WAS UNABLE TO CUT THE POLYP. RESISTANCE WAS NOTED IN THE HANDLE, AFTER WHICH THE SNARE MECHANISM BECAME NONFUNCTIONAL AND WOULD NOT OPEN OR CLOSE. NO CAUTERY OCCURRED NOR ANY ENERGY WAS APPLIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981993 ↗
• MalfunctionMar 6, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THERE WERE A COUPLE SNARES THAT MALFUNCTION WHEN TRYING TO CUT A POLYP. THE SNARES WOULD EITHER NOT CUT ALL THE WAY AND THE WIRE WOULD BREAK AWAY FROM THE HANDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE PROCEDURE; THIS ENTRY SPECIFICALLY REFERS TO THE SECOND DEVICE, WHICH CORRESPONDS TO THE FAILURE MODE "NOT CUTTING THROUGH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531260 ↗
• MalfunctionMar 3, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE COULD NOT BE USED AS A COLD SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495257 ↗
• MalfunctionFeb 25, 2026Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A POLYPECTOMY PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CAPTIVATOR DID NOT CUT AND THERE WAS NO COAGULATION POSSIBLE. ANOTHER CAPTIVATOR SNARE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443492 ↗
• MalfunctionFeb 10, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED FOR POLYP REMOVAL DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE DEVICE WAS USED INSIDE THE PATIENT, THE SNARE LOOP CLOSED BUT IT WOULD NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVEN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304127 ↗
• MalfunctionJan 29, 2026Break; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE SNARES WERE INITIALLY UNABLE TO FULLY CUT THE POLYP, AND WHEN THEY EVENTUALLY DID, THE SNARE WIRE BROKE. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209150 ↗
• MalfunctionDec 22, 2025Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SNARE WOULD NOT CLOSE, EVEN WHEN NOT AROUND TISSUE. THE SNARE LOOP WAS NOT ABLE TO CAPTURE AND CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868081 ↗
• MalfunctionDec 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS OBSERVED THAT THERE WAS A DUST INSIDE THE DEVICE. 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 23769376 ↗
• MalfunctionOct 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE SNARE WOULD NOT CUT THROUGH A POLYP WITH CAUTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 23381322 ↗
• InjurySep 12, 2025Failure to Cut; Difficult to Open or Close; Material Twisted/Bent; Failure to Cut; Difficult to Open or Close; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE TRANSVERSE COLON NEAR THE SPLENIC FLEXURE OF THE LARGE INTESTINE TO REMOVE AN APPROXIMATELY 5MM BENIGN COLORECTAL POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED WITHOUT RESISTANCE, AND THE SNARE WIRE WAS DEPLOYED TO CAPTURE THE POLYP. HOWEVER, MECHANICAL RESECTION WAS UNSUCCESSFUL, AND DURING MANIPULATION PARTICULARLY WHILE STRANGULATING AND SQUEEZING THE POLYP; A PINCHING SENSATION WAS NOTED, DEVIATING FROM THE EXPECTED SMOOTH OPERATION. THE SCOPE WAS THEN USED TO ATTEMPT RESECTION, WHICH RESULTED IN SHEATH DEFORMATION AND A SMALL PERFORATION AT THE ULCER BASE, EXPOSING THE SEROUS MEMBRANE AFTER REMOVAL OF THE MUSCULAR LAYER. THE DEFORMATION, DESCRIBED AS ACCORDION-LIKE BENDING OF THE SNARE WORKING LENGTH, WAS ONLY OBSERVED POST-PROCEDURE AND ATTRIBUTED TO FORCE APPLIED WHEN THE LESION COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. A PERFORATION OCCURRED IN THE COLON WALL DURING THE PROCEDURE BUT WAS SUCCESSFULLY TREATED USING CLIP CLOSURE, CONFIRMED VIA VISUAL INSPECTION WITH AN ENDOSCOPE. THERE WERE

  Patient problems: Perforation

  MAUDE report 23038071 ↗
• MalfunctionSep 9, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CAUTERY DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE REPORT PERTAINS TO 1 OF 2 DEVICES USED IN THE SAME PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007000 ↗
• MalfunctionSep 8, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CAUTERY DID NOT WORK. 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 22992970 ↗
• MalfunctionSep 4, 2025Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED FOR POLYP RESECTION DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE HANDLE WAS REPEATEDLY OPENED AND CLOSED, HOWEVER THE SNARE WOULD NOT RETRACT AND FAILED TO CUT THE POLYP. 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 22963030 ↗
• MalfunctionSep 4, 2025Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED FOR POLYP RESECTION DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE HANDLE WAS REPEATEDLY OPENED AND CLOSED, HOWEVER THE SNARE WOULD NOT RETRACT AND FAILED TO CUT THE POLYP. 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 22963017 ↗
• MalfunctionSep 3, 2025Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED FOR POLYP RESECTION DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT RESPOND PROPERLY WHEN OPENING AND CLOSING THE HANDLE. THEY REPEATEDLY OPENED AND CLOSED THE HANDLE, AND THE SNARE WOULD NOT RETRACT. THEY PROVIDED A PHOTO SAMPLE WHEREIN IT STATES THAT WHEN THEY OPEN THE DEVICE, IT WOULD NOT CLOSE AGAIN. IT GOT STUCK INSIDE AND DO NOT CUT POLYPS. 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 22950851 ↗
• MalfunctionAug 13, 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 DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE POLYP COULD NOT BE RESECTED DUE TO ENERGIZATION PROBLEM. EVEN AFTER SWITCHING TO COLD RESECTION, IT STILL COULD NOT BE RESECTED. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT 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 22793890 ↗
• MalfunctionJul 7, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WOULD NOT CUT. 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 22422659 ↗
• MalfunctionJul 4, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WOULD NOT CUT. 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 22404811 ↗