PROFILE M00562570Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729748038), received between Oct 27, 2021 and Apr 22, 2025 — classified as 1 injury, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SNARE DEVICE WAS USED FOR A POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE METAL STRING IN THE HANDLE PART WAS BENT. ADDITIONALLY, THE SNARE LOOP FAILED TO CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885297 ↗
• MalfunctionJun 15, 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 17134636 ↗
• 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 (B)(6) 2015 TO (B)(6) 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 17128664 ↗
• MalfunctionApr 17, 2023Failure 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 PROFILE MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE HAS NO ELECTRICAL CURRENT DETECTED. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751480 ↗
• MalfunctionOct 27, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-05513 AND 3005099803-2021-05514 FOR THE ASSOCIATED REPORTABLE DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE MEDIUM OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT PRODUCE HEAT AND WOULD NOT CAUTERIZE THE TARGET POLYP. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND HAD NO PROBLEMS WITH THE CAUTERY PINS. THERE WAS AN ATTEMPT TO APPLY CAUTERY AND MULTIPLE CAUTERY BOXES WERE TRIED BUT DID NOT SHOW ANY SIGNS TO THE TARGET POLYP. A SECOND PROFILE SNARE WAS ALSO UNABLE TO PRODUCE HEAT AND WOULD NOT CAUTERIZE THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707344 ↗
• MalfunctionOct 27, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2021-05514 FOR THE ASSOCIATED REPORTABLE DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE MEDIUM OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT PRODUCE HEAT AND WOULD NOT CAUTERIZE THE TARGET POLYP. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND HAD NO PROBLEMS WITH THE CAUTERY PINS. THERE WAS AN ATTEMPT TO APPLY CAUTERY AND MULTIPLE CAUTERY BOXES WERE TRIED BUT DID NOT SHOW ANY SIGNS TO THE TARGET POLYP. A SECOND PROFILE SNARE WAS ALSO UNABLE TO PRODUCE HEAT AND WOULD NOT CAUTERIZE THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707269 ↗