CAPTIVATORRecalls & reported problems across all models

We found 7 models of CAPTIVATOR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 292 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Sep 10, 2026 — classified as 31 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (175 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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 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 5 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-2763-2020 · 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-2762-2020 · Root cause: Device Design · Recall details · FDA record ↗

4. 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-2761-2020 · Root cause: Device Design · Recall details · FDA record ↗

5. 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-2760-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported CAPTIVATOR problems

CAPTIVATOR models

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

• CAPTIVATOR M00562340

  SNARE, FLEXIBLE
  2 recalls71 reports
• CAPTIVATOR M00562320

  SNARE, FLEXIBLE
  2 recalls32 reports
• CAPTIVATOR M00562300

  SNARE, FLEXIBLE
  1 recall78 reports
• CAPTIVATOR M00561310

  SNARE, FLEXIBLE
  2 recalls21 reports
• CAPTIVATOR M00562450

  SNARE, FLEXIBLE
  1 recall71 reports
• CAPTIVATOR M00562370

  SNARE, FLEXIBLE
  1 recall9 reports
• CAPTIVATOR M00562390

  SNARE, FLEXIBLE
  10 reports

Recent CAPTIVATOR adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612248 ↗
• MalfunctionSep 4, 2026Failure to Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611578 ↗
• MalfunctionJul 30, 2026Electrical /Electronic Property Problem; Failure to Cut

  It was reported to Boston Scientific Corporation that a Captivator Snare was used in the colon during a colonoscopy procedure performed on unknown date.During the procedure, the physician was unable to successfully cut a polyp. After that, when cauterization was applied the snare loop sparked and was unable to successfully cauterize the polyp site. 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 50093023 ↗
• MalfunctionJun 25, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS INTENDED TO BE USED IN THE GASTROINTESTINAL TRACT DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE DID NOT POWER ON, WHICH MADE IT UNABLE TO FUNCTION NORMALLY AND RESULTED IN A MINOR DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE 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 25622772 ↗
• MalfunctionJun 25, 2026Failure to Deliver Energy

  It was reported to Boston Scientific that a Captivator Snare was used for a Polypectomy procedure performed on an unknown date.During the procedure the Snare cut without coagulating. The procedure was completed with the same device without coagulation.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 25622724 ↗
• InjuryJun 5, 2026Break; Entrapment of Device; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED FOR AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE WIRE BROKE AND COULD NOT BE CLOSED WHILE IN USE. AS A RESULT, THE SNARE BECAME EMBEDDED IN THE PATIENT TISSUE. CAUTERY WAS APPLIED TO REMOVE THE DEVICE FROM THE TISSUE. 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 25415160 ↗
• InjuryJun 4, 2026Break; Entrapment of Device; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026, FOR A POLYP REMOVAL. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP WITH CAUTERY, BUT THE SNARE FAILED TO CUT AND INSTEAD THE LOOP BECAME EMBEDDED IN THE TARGET POLYP. THE SHEATH AND HANDLE OF THE SNARE WERE CUT, AND THE SNARE WAS WITHDRAWN FROM THE SCOPE. A NEW SNARE WAS USED TO CUT THE POLYP AND TO REMOVE THE ORIGINAL SNARE FROM THE PATIENTS TISSUE. THE POLYP SITE WAS CLOSED USING CLIPS. UPON EXAMINATION AFTER THE PROCEDURE, THE PRONG ON THE ORIGINAL SNARE WAS FOUND TO BE LOOSE. THE EVENT RESULTED IN PATIENT PERFORATION AND PROLONGED HOSPITALIZATION BEYOND STANDARD CARE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 25394962 ↗
• 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 ↗
• MalfunctionMar 12, 2026Nonstandard Device; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARES WAS USED TO REMOVE A LARGE POLYP IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CABLE WAS CONNECTED TO THE SNARE, AND CAUTERY WAS APPLIED TO CUT THROUGH THE POLYP. WHEN THEY OBSERVED THAT THE CUT WAS NOT PROGRESSING AS EXPECTED, THEY STOPPED THE CAUTERY AND INSPECTED THE DEVICE. IT WAS NOTED THAT THE PLASTIC SHEATH HAD SLIGHTLY MELTED AND APPEARED DEFORMED, BUT IT REMAINED ATTACHED. THE PROCEDURE WAS COMPLETED USING 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 24581372 ↗
• MalfunctionMar 12, 2026Nonstandard Device; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CABLE WAS CONNECTED TO THE SNARE AND CAUTERY WAS APPLIED TO CUT THROUGH THE POLYP. WHEN THEY OBSERVED THAT THE CUT WAS NOT PROGRESSING FULLY, THEY STOPPED THE CAUTERY AND INSPECTED THE DEVICE, NOTING THAT THE PLASTIC SHEATH HAD SLIGHTLY MELTED. 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 24580871 ↗
• MalfunctionJan 30, 2026Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARES WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT WHEN THE PHYSICIAN APPLIED CAUTERY AND CLOSED THE SNARE, A SMALL PIECE OF POLYP, APPEARED TO BECOME CAUGHT IN THE SHEATH, WHICH PREVENTED THE SNARE FROM FULLY CUTTING THE POLYP. 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 24222024 ↗
• 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 ↗
• MalfunctionJan 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS POSITIONED AROUND THE POLYP, BUT WHEN THE PEDAL WAS ACTIVATED, THE SNARE UNABLE TO CUT. 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 24093496 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports