CAPTIVATOR IIRecalls & reported problems across all models

We found 5 models of CAPTIVATOR II by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 324 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Sep 3, 2026 — classified as 28 injuries, 296 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (144 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

CAPTIVATOR II 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-1169-2021 · 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-2759-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported CAPTIVATOR II problems

CAPTIVATOR II models

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

• CAPTIVATOR II M00561220

  SNARE, NON-ELECTRICAL
  1 recall150 reports
• CAPTIVATOR II M00561230

  SNARE, FLEXIBLE
  1 recall83 reports
• CAPTIVATOR II M00561290

  SNARE, FLEXIBLE
  1 recall43 reports
• CAPTIVATOR II M00561190

  SNARE, FLEXIBLE
  1 recall22 reports
• CAPTIVATOR II M00561240

  SNARE, NON-ELECTRICAL
  26 reports

Recent CAPTIVATOR II 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 Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599423 ↗
• MalfunctionSep 1, 2026Break; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550085 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that a Captivator Snare was intended to be used in the colon during a polypectomy procedure performed on (b)(6) 2026.Prior to the procedure, during the equipment preparation process on the trolley, the connector shaft attached to the cautery cable became detached from its locking mechanism. The procedure was completed with another of the same device.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 50533769 ↗
• MalfunctionJul 21, 2026Failure to Cut; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25891633 ↗
• 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 20, 2026Electrical /Electronic Property Problem; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882156 ↗
• MalfunctionJul 8, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARE WAS USED IN THE STOMACH DURING A POLYPECTOMY PROCEDURE FOR THE REMOVAL OF AN 8 MM POLYP, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN CAPTURED THE POLYP, HE PUSHED THE PEDAL TO HOT POLYPECTOMY, HOWEVER, NOTHING HAPPENED. 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 25751095 ↗
• MalfunctionJul 7, 2026Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED FOR A COLD POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO CUT EASILY THE TARGET POLYP. PROCEDURE WAS COMPLETED WITH HEAT ADDED TO THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738468 ↗
• MalfunctionJul 7, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738448 ↗
• MalfunctionJul 1, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE INTESTINAL TRACT FOR AN ESOPHAGEAL ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO DELIVER ENERGY. 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 25682434 ↗
• MalfunctionJun 30, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO COLD CUT A PEDUNCULATED POLYP. AFTER THAT, THE DEVICE WAS UNABLE TO DELIVER HEAT WHEN SOFT COAGULATION WAS ATTEMPTED TO CAUTERIZE THE POLYP SITE. AS A RESULT, CLIPS WERE PLACED TO STOP THE BLEEDING AT POLYP SITE. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25673471 ↗
• 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 ↗
• MalfunctionJun 9, 2026Break; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE LOOP, BUT IT WAS UNABLE TO EXTEND, ADDITIONALLY THE LOOP GOT BROKEN. 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 25446896 ↗

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