PROFILE M00562550Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729748021), received between Nov 17, 2016 and Oct 30, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SNARE WAS TO BE USED DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE SNARE DID NOT CUT THROUGH THE POLYP. 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 23423296 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THROUGH THE ARTICLE "SAFETY AND EFFICACY OF COLD SNARE POLYPECTOMY FOR SMALL COLORECTAL POLYPS" WRITTEN BY TAKAHIRO ITO, ET AL. ACCORDING TO THE LITERATURE, 119 PATIENTS WERE RECRUITED FOR THIS STUDY AND UNDERWENT POLYPECTOMY AT ASAHIKAWA-KOUSEI GENERAL HOSPITAL FROM MAY 2015 TO MAY 2016. THE PARTICIPANTS WERE RANDOMIZED, WITH 59 PATIENTS ASSIGNED TO THE COLD SNARE POLYPECTOMY GROUP. A TOTAL OF 458 POLYPS WERE RESECTED FROM THE PARTICIPANTS OF BOTH GROUPS. COLD SNARE POLYPECTOMY WAS PERFORMED WITH A SMALL OVAL FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE OR A MEDIUM FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE. IT WAS REPORTED THAT A PATIENT HAD DELAYED BLEEDING REQUIRING INTERVENTION. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17129121 ↗
• MalfunctionJun 14, 2023Failure to Cut; Failure to Cut

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THROUGH THE ARTICLE "SAFETY AND EFFICACY OF COLD SNARE POLYPECTOMY FOR SMALL COLORECTAL POLYPS" WRITTEN BY TAKAHIRO ITO, ET AL. ACCORDING TO THE LITERATURE, 119 PATIENTS WERE RECRUITED FOR THIS STUDY AND UNDERWENT POLYPECTOMY AT ASAHIKAWA-KOUSEI GENERAL HOSPITAL FROM MAY 2015 TO MAY 2016. THE PARTICIPANTS WERE RANDOMIZED, WITH 59 PATIENTS ASSIGNED TO THE COLD SNARE POLYPECTOMY GROUP. A TOTAL OF 458 POLYPS WERE RESECTED FROM THE PARTICIPANTS OF BOTH GROUPS. COLD SNARE POLYPECTOMY WAS PERFORMED WITH A SMALL OVAL FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE OR A MEDIUM FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE. IT WAS REPORTED THAT THREE POLYPS WERE NOT SUCCESSFULLY RESECTED IN THE COLD SNARE POLYPECTOMY GROUP AND WERE REMOVED ELECTRICALLY. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126480 ↗
• MalfunctionDec 31, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SMALL OVAL FLEXIBLE SNARE WAS USED IN THE BILE DUCT FOR STENT REMOVAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE STENT REMOVAL PROCEDURE, THE SNARE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 FINE. NOTE: IT WAS REPORTED THAT THE PHYSICIAN WENT TO DO A STENT PULL WITH A PROFILE SNARE. HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), THE SINGLE-USE POLYPECTOMY SNARES ARE INDICATED FOR USE IN THE REMOVAL AND CAUTERIZATION OF DIMINUITIVE POLYPS, SESSILE POLYPS, AND PEDUNCULATED POLYPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125005 ↗
• InjuryOct 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER OPENING AND CLOSING THE DEVICE SEVERAL TIMES, THE SNARE LOOP BROKE AND FELL OFF INSIDE THE PATIENT. THE BROKEN SNARE LOOP WAS RETRIEVED USING GRASPERS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662119 ↗
• MalfunctionFeb 6, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SMALL OVAL SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY HAD DIFFICULTY CAPTURING THE POLYP AND WHEN ATTEMPTING TO REMOVE THE TARGET POLYP, THE LOOP FAILED TO CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD ¿NO PROBLEM¿ AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6304110 ↗
• MalfunctionNov 17, 2016Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SMALL OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING A COLD SNARING PROCEDURE, THE SNARE LOOP FAILED TO CUT THE TARGET POLYP. THE PHYSICIAN NOTICED THAT THE DEVICE ROTATED DURING RETRACTION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE USING CAUTERY. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6110804 ↗