CAPTIFLEXRecalls & reported problems across all models

We found 3 models of CAPTIFLEX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 174 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Sep 3, 2026 — classified as 15 injuries, 159 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (122 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CAPTIFLEX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

2. Jul 6, 2020Open, Classified

   BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

   Z-2765-2020 · Root cause: Device Design · Recall details · FDA record ↗

3. Jul 6, 2020Open, Classified

   BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

   Z-2764-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported CAPTIFLEX problems

CAPTIFLEX models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CAPTIFLEX M00562400

  SNARE, FLEXIBLE
  3 recalls85 reports
• CAPTIFLEX M00562420

  SNARE, FLEXIBLE
  1 recall69 reports
• CAPTIFLEX M00562470

  SNARE, FLEXIBLE
  1 recall20 reports

Recent CAPTIFLEX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Cut; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600015 ↗
• MalfunctionJul 7, 2026Retraction Problem; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE WAS NOT FULLY SNAPPING CLOSED AT TIMES AND HAD ISSUES RESECTING THE POLYPS. 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 25733101 ↗
• MalfunctionMar 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602402 ↗
• MalfunctionMar 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602393 ↗
• MalfunctionMar 13, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590383 ↗
• MalfunctionMar 13, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588963 ↗
• MalfunctionMar 12, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED FOR SCREENING IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. 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 24579721 ↗
• 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 ↗
• MalfunctionMar 4, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505636 ↗
• 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 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARES DEVICE WAS USED FOR POLYPECTOMY DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE HANDLE PIECE STARTED FALLING APART, AND THE CAUTERY PORT METAL FELL OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699374 ↗

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