CAPTIVATOR M00562300Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 08714729747833), received between Dec 6, 2016 and Sep 10, 2026 — classified as 7 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (45 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 18, 2026.

Recalls naming this device

1. Jan 19, 2021Class IIOpen, Classified

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

   Z-1168-2021 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Retraction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722737 ↗
• MalfunctionMay 12, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS INTENDED TO BE USE DURING A MUCOSECTOMY PROCEDURE PERFORMED (B)(6) 2026. PRIOR TO THE PROCEDURE, THE SNARE FAILED TO MAKE CONTACT WITH THE GENERATOR AND WOULD NOT DELIVER ENERGY. 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 25150119 ↗
• MalfunctionJan 29, 2026Break; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  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 24209420 ↗
• MalfunctionJan 27, 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 24188446 ↗
• MalfunctionDec 8, 2025Detachment 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 A CAPTIVATOR SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE CAUTERY PIN WAS BROKEN AND DETACHED. 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 23742439 ↗
• MalfunctionNov 25, 2025Retraction Problem; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE TECH THAT WAS IN THE PROCEDURE OPENED THE SNARE, AND WRAPPED IT AROUND THE POLYP AND THEN TRIED TO CLOSE THE SNARE, THE SNARE WOULD NOT CLOSE. 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 23648447 ↗
• InjuryNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE DISCONNECTED. THE SNARE PIECE WAS RETRIEVED FROM THE PATIENT USING A FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 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 23452422 ↗
• MalfunctionOct 22, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A 1CM INTESTINAL POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE COULD NOT 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 23356286 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED FOR UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, ONE CAPTIVATOR SMALL OVAL BROKE AFTER ONE USE. 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 23074348 ↗
• MalfunctionAug 20, 2025Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, DURING REMOVAL OF THE POLYP, USING THE CAUTERY, THE POWER OF THE CAUTERY WAS APPARENTLY NOT TRANSFERRED TO THE LOOP RESULTING TO CUTTING INCORRECTLY. THERE WAS NO INFORMATION WITH THE OUTCOME OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848504 ↗
• MalfunctionAug 4, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE INTESTINAL TRACT TO REMOVE 5 MM GASTROINTESTINAL POLYPS DURING AN ENDOSCOPIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE PHYSICIAN USED AN ENDOSCOPE TO TRAP THE POLYPS FOR COLD RESECTION. HOWEVER, THE LOOP WAS UNABLE TO CUT THE POLYP. THE PROCEDURE WAS EXTENDED FOR 10 MINUTES AND 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 22699372 ↗
• MalfunctionJul 18, 2025Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING A COLD INCISION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE COULD NOT FULLY EXTEND, PREVENTING COMPLETE CAPTURE OF THE POLYPS. 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 22543673 ↗
• MalfunctionJul 18, 2025Mechanical Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON FOR THE EXCISION OF COLONIC POLYP DURING A COLD RESECTION OF INTESTINAL POLYPS PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE COULD NOT EXTEND COMPLETELY. THE SNARE WAS UNABLE TO CUT THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543424 ↗
• MalfunctionJul 4, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARES WAS USED IN THE LARGE INTESTINE DURING A POLYPECTOMY PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE SNARES FROM THIS LOT WERE NOT EFFECTIVELY CUTTING TISSUE AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22404812 ↗
• InjuryMay 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - -SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE COULD NOT BE FULLY EXTENDED, WHICH LED TO LONGER TREATMENT DURATION, INCREASED BLEEDING AT THE WOUND SITE, AND MULTIPLE ATTEMPTS WERE REQUIRED AFTERWARD TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR - SNARE DEVICE. ADDITIONAL INFORMATION RECEIVED ON MAY 29, 2025: THE PROCEDURE PERFORMED WAS A RESECTION OF COLONIC POLYPS IN THE COLON. THE PROCEDURE WAS DELAYED FOR 15 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22095549 ↗
• MalfunctionApr 30, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE INTESTINAL POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE COULD NOT BE ENERGIZED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 23, 2025. THE SNARE WAS USED IN THE DESCENDING COLON TO REMOVE A 13 MM FLAT POLYP DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE SNARE WAS SECURELY ATTACHED TO ACTIVE CORD AND THERE WERE NO PROBLEMS NOTED WITH THE CAUTERY PIN. NO ATTEMPTS WERE MADE TO COLD CUT THE POLYP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938186 ↗
• MalfunctionApr 2, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR-SNARES WAS USED IN THE COLON TO TREAT POLYPS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO COMPLETELY SNARE THE POLYPS, RESULTING IN INCOMPLETE RESECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR-SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758784 ↗
• MalfunctionMar 19, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL STIFF SNARE WAS USED IN THE STOMACH DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED PRIOR TO THE PROCEDURE, IT WAS FOUND THAT THE HANDLE WAS BROKEN AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR SMALL OVAL STIFF 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. 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 21646329 ↗
• MalfunctionSep 27, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(4) 2024. DURING THE PROCEDURE, HOT SNARE DID NOT CREATE HEAT FOR POLYP REMOVAL DESPITE ALL INDICATORS BEING GREEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323350 ↗
• MalfunctionMay 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON TO REMOVE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER INSERTING THE SNARE AND CATCHING THE POLYP, THEY ATTEMPTED TO PULL BACK THE LOOP BUT COULD NOT CUT THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359436 ↗
• MalfunctionMay 15, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON TO REMOVE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER INSERTING THE SNARE AND CATCHING THE POLYP, THEY ATTEMPTED TO PULL BACK THE LOOP BUT COULD NOT CUT THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323407 ↗
• MalfunctionMar 25, 2024Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE HAD ELECTRICAL PROBLEM AND CAUTERY WAS NOT WORKING AND WAS NOT CUTTING THROUGH THE TISSUE. 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 18969033 ↗
• MalfunctionDec 27, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE RECTUM TO REMOVE POLYPS DURING A RECTAL POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WIRE DID NOT CUT SMOOTHLY. THE SPECIMEN WAS DAMAGED AND COULD NOT BE SENT FOR TESTING. 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 SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405842 ↗
• MalfunctionDec 12, 2023Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE INTESTINAL TRACTS TO TREAT COLON POLYPS DURING AN ENDOSCOPIC RECTAL THERAPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE WAS ENCLOSED TO THE POLYP AND DURING FRAPING, THE TIP TURNED CLOCKWISE IN SMALL CIRCLES CAUSING THE POLYP TO CRUSH. THEY FAILED TO COMPLETE THE RESECTION, AND THE SPECIMEN WAS TOO SMALL TO BE SENT FOR TESTING. 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 STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18314487 ↗
• InjuryNov 21, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A POLYP AROUND 0.8 CM IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE POLYP WAS NOT SEPARATED SMOOTHLY DUE TO THE LARGE BLUNTNESS OF THE SNARE. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO PROBLEMS NOTED WITH THE CAUTERY PIN. THEY MADE SEVERAL CUTS, AND IT SUCCESSFULLY SEPARATED THE POLYP. HOWEVER, THE PATIENT'S WOUND AREA INCREASED AND CAUSED A MUCOSAL AVULSION. THEREFORE, THE PHYSICIAN USED A HEMOSTATIC CLIP TO CLOSE THE WOUND. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL SNARE USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18180550 ↗