PROFILERecalls & reported problems across all models

We found 3 models of PROFILE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Oct 30, 2025 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (17 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. 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

Most reported PROFILE problems

PROFILE models

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

• PROFILE M00562530

  SNARE, FLEXIBLE
  14 reports
• PROFILE M00562550

  SNARE, FLEXIBLE
  7 reports
• PROFILE M00562570

  SNARE, FLEXIBLE
  6 reports

Recent PROFILE adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionOct 4, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLORECTAL POLYP RESECTION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A PROBLEM WITH THE ENERGIZATION HAS OCCURRED. THE SNARE AND ACTIVE CORD WERE SECURELY CONNECTED, AND NO ABNORMALITIES WERE NOTED WITH THE ABLATION PINS. 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 17869888 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 25, 2022Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED TO REMOVE POLYPS IN THE COLON DURING AN ENDOSCOPIC COLORECTAL POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LESION WAS STRANGULATED AND ENERGIZED, BUT IT DID NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE PROFILE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670450 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS TO BE USED DURING A PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT, A DIRT ON THE HANDLE PART FOUND INSIDE THE STERILE POUCH WAS CONFIRMED TO HAVE ADHERED BEFORE THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE SNARE. 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 12675182 ↗
• MalfunctionSep 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS INSPECTED BEFORE DELIVERY TO THE CUSTOMER PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT SOMETHING THAT LOOKED LIKE AN EYELASHES WAS FOUND INSIDE THE UNOPENED STERILE POUCH. REPORTEDLY, THIS WAS FOUND BEFORE DELIVERY TO THE CUSTOMER AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542016 ↗
• MalfunctionMar 3, 2021Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AFTER EXCISING THREE POLYPS WITHOUT ENERGIZATION, WHEN STRANGULATING THE FOURTH ONE, IT WAS UNABLE TO CUT AT ALL. WHEN THE SNARE WAS REMOVED FROM THE ENDOSCOPE AND CHECKED, IT WAS REPORTED THAT THE WIRE WAS BENT, AND THE PROCEDURE COULD NOT BE COMPLETED WITH THAT SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404121 ↗

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