Captivator™ COLD M00561100Recalls & reported problems

Summary

The FDA's MAUDE database contains 377 adverse event reports that list this exact device (DI 08714729971252), received between Nov 19, 2018 and Sep 18, 2026 — classified as 37 injuries, 340 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (265 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 377 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported to Boston Scientific Corporation that a Captivator Cold Snare was used in a polypectomy procedure performed on (b)(6)2026.During the procedure, the snare broke when the first cold polypectomy resection was done. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event.No additional information has been received despite Good Faith Efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820518 ↗
• MalfunctionSep 17, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809502 ↗
• MalfunctionSep 17, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809491 ↗
• MalfunctionSep 17, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809185 ↗
• MalfunctionSep 17, 2026Failure to Cut

  It was reported to Boston Scientific Corporation that a Cold Snare was used during a colonoscopy procedure performed on an unknown date.During the procedure, the snare loop was unable to cut the polyp. Additional force on the handle was used to close the snare, but the poly was still not able to be cut. 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 50803545 ↗
• MalfunctionSep 8, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677217 ↗
• MalfunctionAug 10, 2026Mechanical Problem; Retraction Problem; Failure to Cut; Difficult to Open or Close

  It was reported to Boston Scientific Corporation that a Captivator COLD Single-use snare was used in the colon for a Colonic polypectomy procedure performed on an unknown date.During the procedure the Snare was stiff when opening and closing and could not cut the polyp. 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 50196983 ↗
• MalfunctionJul 15, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO CUT THE POLYP. 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 25829154 ↗
• MalfunctionJun 15, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A COLD SNARE WAS USED FOR A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE SNARE FAILED TO CUT THE POLYP. 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 25498616 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A COLD SNARE WAS USED FOR A POLYP REMOVAL, DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE LOOP DETACHED FROM THE DEVICE. THE LOOP WAS REMOVED FROM THE PATIENT WITH THE SAME DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356317 ↗
• MalfunctionMay 15, 2026Mechanical Problem; Failure to Cut; Difficult to Open or Close

  It was reported to Boston Scientific that a Cold Snare was used for a Polypectomy procedure performed on an unknown date.During the procedure when advancing and retracting, the snare would not respond properly, it did tend to get stuck and the cutting performance was not effective. Unknown how 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 25191494 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD SNARE DEVICE WAS USED FOR POLYPECTOMY DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A METAL PIECE OF THE SNARE CAME OUT OF THE PLASTIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER COLD SNARE 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 25021462 ↗
• MalfunctionApr 28, 2026Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR COLD 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 AND THE SNARE WAS UNABLE TO CUT COLD. THE SNARE WAS ACTUATING WITH RESISTANCE WHEN TRYING TO OPEN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017826 ↗
• MalfunctionApr 16, 2026

  FROM STAFF: UPON OPENING SNARE FROM PACKAGING TO PREPARE FOR CASE, THE DEVICE BUCKLED AND WAS NOT FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895125 ↗
• MalfunctionMar 30, 2026Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD SNARE WAS USED IN THE COLON DURING A COLONOSCOPY. THE EXACT PROCEDURE DATE WAS UNKNOWN. IT WAS REPORTED THAT THE WIRE SNAPPED DURING POLYP REMOVAL. THE PROCEDURE WAS COMPLETED, ALTHOUGH THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH THE CASE. THE PATIENT SUBSEQUENTLY UNDERWENT AN MRI, AND THE SCOPE INVOLVED IN THE EVENT IS CURRENTLY BEING REPAIRED. 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 24717368 ↗
• MalfunctionMar 25, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON FOR A POLYPECTOMY REMOVAL PROCEDURE, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE FAILED TO CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690876 ↗
• MalfunctionMar 24, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON FOR A POLYPECTOMY REMOVAL PROCEDURE, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE FAILED TO CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680716 ↗
• MalfunctionMar 24, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON FOR A POLYPECTOMY REMOVAL PROCEDURE, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE FAILED TO CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680645 ↗
• MalfunctionMar 24, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON FOR A POLYPECTOMY REMOVAL PROCEDURE, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE FAILED TO CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674483 ↗
• MalfunctionMar 24, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON FOR A POLYPECTOMY REMOVAL PROCEDURE, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE FAILED TO CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674475 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR COLD SINGLE-USE SNARE WAS USED DURING A COLONOSCOPY FOR THE TREATMENT OF POLYPS, ON (B)(6) 2026. DURING THE PROCEDURE, THE LOOP SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR COLD SINGLE-USE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619284 ↗
• MalfunctionMar 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR COLD SNARE WAS USED IN THE COLON FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CAPTIVATOR COLD SNARE FAILED TO CUT THE POLYP. ANOTHER UNKNOWN ALTERNATIVE METHOD WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605980 ↗
• InjuryMar 9, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2026. IT WAS REPORTED THAT THE PROCEDURE TOOK LONGER BECAUSE THE STAFF HAD TO WITHDRAW THE SNARE AND RETRIEVE IT USING A GRASPING FORCEPS. IN ADDITION, THE SNARE TIP HAD MIGRATED INTO THE LUMEN OF THE GUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542361 ↗
• MalfunctionFeb 24, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR COLD SINGLE-USE SNARE DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF POLYPS REMOVAL. DURING THE PROCEDURE, THE LOOP WOULD NOT CUT THROUGH THE POLYP. TROUBLESHOOTING STEPS WERE ATTEMPTED TO RESOLVE THE ISSUE, INCLUDING TRYING NUMEROUS TIMES. DESPITE THESE EFFORTS, THE PHYSICIAN HAD TO CHANGE THE DEVICE WITH ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428161 ↗
• MalfunctionFeb 18, 2026Retraction Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR COLD SINGLE-USE SNARE WAS USED DURING A POLYP RETRIEVAL PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS DIFFICULT TO CLOSE THE SNARE SLOWLY AROUND THE POLYP. THE SNARE CLOSED RAPIDLY, RESULTING IN INADVERTENT CUTTING OF THE POLYP. THE POLYP WAS RETRIEVED, BUT NOT IN THE MANNER THE PHYSICIAN INTENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381411 ↗