CAPTIFLEX M00562470Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729747994), received between May 31, 2018 and Mar 6, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 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-1168-2021 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX OVAL FLEXIBLE 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 FIRST DEVICE, WHICH CORRESPONDS TO THE FAILURE MODE "SNARE WIRE BROKE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531280 ↗
• MalfunctionJan 8, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARES DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN USING THE HANDLE, IT WAS OBSERVED THAT THE DEVICE WAS NOT CONDUCTING CURRENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006573 ↗
• MalfunctionNov 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED DURING A POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT A FAILURE OF CAUTERY DURING AN ATTEMPT TO HOT SNARE A LARGE SIGMOID POLYP. 11MM EXTRA SMALL OVAL FLEXIBLE SNARE WAS BEING USED AND WAS HOOKED UP TO THE CAUTERY MACHINE. CAUTERY WOULD WORK INTERMITTENTLY, NOT CAUTERIZING ALL THE WAY THROUGH THE COLON POLYP. THE CONNECTION BETWEEN THE SNARE AND THE CAUTERY CORD SEEMED TO NOT BE TIGHT ONCE CLICKED IN. 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 23623811 ↗
• MalfunctionOct 30, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS TO BE USED DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THERE WAS NO CAUTERY ENERGY WITH THE SNARE. ACCOUNT ASSURED THEY HAVE THE SETTINGS AND ERBY MACHINE SET THE SAME WAY FOR EVERY PROCEDURE. 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 23423342 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Failure to Cut; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Mechanical 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 CAPTIFLEX SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO EXTEND THE SNARE FROM THE PLASTIC SHEATH, WHICH SHOWED SIGNS OF IMMINENT BREAKAGE DUE TO RESISTANCE ENCOUNTERED WHILE ACTUATING THE DEVICE. IN ADDITION, IT WAS ALSO MENTIONED THAT THERE WAS A CUTTING ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23235567 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Failure to Cut; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Mechanical Problem; Failure to Cut; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO EXTEND THE SNARE FROM THE PLASTIC SHEATH, WHICH SHOWED SIGNS OF IMMINENT BREAKAGE DUE TO RESISTANCE ENCOUNTERED WHILE ACTUATING THE DEVICE. IN ADDITION, IT WAS ALSO MENTIONED THAT THERE WAS A CUTTING ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23234702 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PROBLEM NOT CUTTING THROUGH POLYPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553090 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PROBLEM NOT CUTTING THROUGH POLYPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552483 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PROBLEM NOT CUTTING THROUGH POLYPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546126 ↗
• MalfunctionOct 28, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PROBLEM NOT CUTTING THROUGH POLYPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546108 ↗
• MalfunctionNov 17, 2023Failure to Deliver Energy; Mechanical Problem; Failure to Deliver Energy; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED DURING A GASTROINTESTINAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE CAUTERY OF THE DEVICE WAS NOT WORKING. NO PROBLEM WAS NOTED WITH THE HANDLE OF THE DEVICE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161030 ↗
• MalfunctionAug 16, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023 ACCORDING TO THE COMPLAINANT, SPARK SHOT OUT DURING USAGE OF DEVICE AND THE SNARE LOOP WAS BROKEN. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557115 ↗
• MalfunctionAug 8, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DOCTORS NOTICED THAT WHEN THEY USE HOT SNARES, THEY ARE NOT CUTTING THROUGH TISSUE AS EFFECTIVELY AS EXPECTED. THEY HAVE TRIED ADJUSTING THEIR GENERATOR SETTINGS, BUT THEY HAVE CONSISTENTLY OBSERVED THIS ISSUE ACROSS DIFFERENT BATCHES OF SNARES AND VARIOUS TYPES OF SNARE FAMILIES. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT IS NOT KNOWN IF THERE WERE ANY PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 11, 2023 : DURING THE PROCEDURE PERFORMED ON (B)(6) 2023, THE PHYSICIAN REMOVED A POLYP USING A SNARE BUT NOTICED THAT THE CENTER OF THE POLYP REMAINED AFTER THE PROCEDURE. THE PROCEDURE WAS REPORTED TO BE 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

  MAUDE report 17481949 ↗
• MalfunctionJul 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE ARE DIFFICULTIES ENCOUNTERED WITH THE 11MM CAPTIFLEX SNARE. THE USE OF CAUTERY RESULTED IN THE BURNING OF THE POLYP, CAUSING THE TISSUE TO BECOME WHITE, BUT THE SNARE ITSELF DID NOT CUT THROUGH. AN EFFORT WAS MADE TO MODIFY THE SETTINGS ON THE ERBE MACHINE, BUT IT DID NOT YIELD THE DESIRED OUTCOME. 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

  MAUDE report 17322170 ↗
• MalfunctionJul 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE ARE DIFFICULTIES ENCOUNTERED WITH THE 11MM CAPTIFLEX SNARE. THE USE OF CAUTERY RESULTED IN THE BURNING OF THE POLYP, CAUSING THE TISSUE TO BECOME WHITE, BUT THE SNARE ITSELF DID NOT CUT THROUGH. AN EFFORT WAS MADE TO MODIFY THE SETTINGS ON THE ERBE MACHINE, BUT IT DID NOT YIELD THE DESIRED OUTCOME. 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

  MAUDE report 17322168 ↗
• MalfunctionJul 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE ARE DIFFICULTIES ENCOUNTERED WITH THE 11MM CAPTIFLEX SNARE. THE USE OF CAUTERY RESULTED IN THE BURNING OF THE POLYP, CAUSING THE TISSUE TO BECOME WHITE, BUT THE SNARE ITSELF DID NOT CUT THROUGH. AN EFFORT WAS MADE TO MODIFY THE SETTINGS ON THE ERBE MACHINE, BUT IT DID NOT YIELD THE DESIRED OUTCOME. 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

  MAUDE report 17322151 ↗
• MalfunctionJul 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE ARE DIFFICULTIES ENCOUNTERED WITH THE 11MM CAPTIFLEX SNARE. THE USE OF CAUTERY RESULTED IN THE BURNING OF THE POLYP, CAUSING THE TISSUE TO BECOME WHITE, BUT THE SNARE ITSELF DID NOT CUT THROUGH. AN EFFORT WAS MADE TO MODIFY THE SETTINGS ON THE ERBE MACHINE, BUT IT DID NOT YIELD THE DESIRED OUTCOME. 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

  MAUDE report 17322132 ↗
• MalfunctionNov 9, 2022Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SNARE IS HAVING DIFFICULTY CUTTING THE POLYPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761624 ↗
• MalfunctionDec 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRASMALL OVAL FLEXIBLE SNARE WAS USED IN THE TRANSVERSE COLON DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP AND DELIVERY SYSTEM WIRE WAS COMPLETELY PULLED APART. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE HEALTHY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413364 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX EXTRA SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE POLYP WAS CUT IT WAS NECESSARY TO USE CAUTERY TO STOP THE BLEEDING AND IT WAS NOTED THAT THE WIRE INSIDE THE HANDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; LOOP BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556597 ↗