Resolution 360 Clip M00521240Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729875666), received between Mar 2, 2018 and Mar 4, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED FOR A POLYP IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE BUT WAS UNABLE TO DEPLOY FROM THE CATHETER INITIALLY. THE PHYSICIAN UNLOCKED THE TISSUE AND ATTEMPTED TO RELEASE THE CLIP AGAIN. THE CLIP EVENTUALLY RELEASED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. 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 STABLE. ADDITIONAL INFORMATION RECEIVED ON MARCH 9, 2026: IT WAS NOTED THAT IT CAME OFF TISSUE; HOWEVER, THE CLIP WAS STILL ATTACHED TO THE CATHETER. UPON REMOVING THE CLIP THROUGH THE SCOPE, THE CLIP FINALLY RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512107 ↗
• MalfunctionJun 18, 2025Activation, Positioning or Separation Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE CHRONIC NON-ATROPHIC (SUPERFICIAL) ANTRAL GASTRITIS AFTER HEMOSTASIS OF MULTIPLE DUODENAL ULCER BLEEDING DURING AN ELECTRONIC GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CLIP COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282718 ↗
• MalfunctionMay 24, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED IN THE ASCENDING COLON FOR POST POLYPECTOMY DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SCOPE WAS IN A DIFFICULT/TWISTED POSITION. THE CLIP WAS PASSED DOWN THE SCOPE BUT WAS BEING PLACED AT A SEVERE ANGLE DUE TO THE ANATOMY AND SCOPE POSITION. THE CLIP WAS ABLE TO BE CLOSED AND DEPLOYED, BUT THE BUSHING WOULD NOT SEPARATE FROM THE CAPSULE. THE HANDLE COULD BE ARTICULATED AND REMOVE THE CATHETER, BUT NO MOVEMENT OCCURRED. THE PHYSICIAN REMOVED THE ENTIRE CLIP BY AVULSING THE CLOSED CLIP FROM THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED IN A TORTUOUS ANATOMY. HOWEVER, ACCORDING TO THE DIRECTIONS FOR USE (DFU), "PASSAGE OF THE RESOLUTION 360 CLIP THROUGH A RETROFLEXED OR TORTUOUS PATH, MAY RESULT IN THE CLIP SEPARATING FROM THE CATHETER AND POTENTIALLY KINKING OR DAMAGING THE DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392499 ↗
• MalfunctionMay 22, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED IN THE COLON FOR HEMOSTASIS DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN PASSED THE CLIP DOWN THE SCOPE AND GRABBED THE TISSUE. DURING THE DEPLOYMENT, THE CATHETER DANGLED ON THE CLIP AND WOULD NOT RELEASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372626 ↗
• MalfunctionMay 14, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE DUODENUM FOR GASTROINTESTINAL BLEEDING (GI) BL DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. INSTEAD OF THE CLIP DEPLOYING AT THE BLEEDER SPOT, IT REMAINED INTACT TO THE CATHETER CAUSING INABILITY TO STOP THE BLEEDING. IT WAS REPORTED THAT ABNORMALLY HIGH RESISTANCE WAS FELT BEFORE THE HANDLE SPOOL REACHED THE END OF THE STROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310839 ↗
• MalfunctionMar 12, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE DUODENUM FOR GASTROINTESTINAL BLEEDING DURING AN ENDOSCOPY OF UPPER GASTROINTESTINAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. INSTEAD OF THE CLIP DEPLOYING AT THE BLEEDER SPOT, THE CLIP REMAINED ATTACHED TO THE CATHETER. DUE TO THE CLIP'S INCAPACITY TO CONTROL THE BLEEDING, THERE WAS SOME BLOOD LOSS. HOWEVER, THIS WAS CONTROLLED BY COMPLETING THE PROCEDURE USING ANOTHER RESOLUTION 360 CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE SCOPE USED WAS A DUODENOSCOPE. HOWEVER, PER THE INSTRUCTIONS FOR USE, HEMOSTASIS CLIP IS DESIGNED TO BE COMPATIBLE WITH FORWARD VIEWING ENDOSCOPES ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890369 ↗
• MalfunctionFeb 21, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753817 ↗
• MalfunctionSep 21, 2022Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS TO BE USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS NOTICED THAT THE CLIP AND THE DELIVERY CATHETER DETACHED IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF BUSHING WAS WIDER THAN USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461352 ↗
• MalfunctionJun 13, 2022Entrapment of Device; Detachment of Device or Device Component; Human-Device Interface Problem; Entrapment of Device; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE FIRST CLIP WAS DEPLOYED SUCCESSFULLY; HOWEVER, WHEN THE PHYSICIAN WENT TO PLACE A SECOND CLIP, RESISTANCE WAS FELT AND THE CLIP COULD NOT PASS THROUGH THE WORKING CHANNEL OF THE SCOPE. THE SCOPE WAS SWITCHED TO A DIFFERENT EGD SCOPE WHERE THE SECOND CLIP WAS ABLE TO PASS THROUGH AND DEPLOYED SUCCESSFULLY. ADDITIONALLY, THE FIRST CLIP UNKNOWINGLY DETACHED FROM THE TISSUE AND GOT STUCK INSIDE THE WORKING CHANNEL OF THE FIRST SCOPE. THIS WAS ONLY DISCOVERED UPON REPROCESSING OF THE SCOPE, WHEN THE FIRST CLIP WAS FLUSHED OUT OF THE WORKING CHANNEL OF THE SCOPE. A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING A CLIP ASSEMBLY AND A YOLK OUTSIDE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674107 ↗
• MalfunctionDec 29, 2021Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE GASTRO ESOPHAGEAL JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER, THE CLIP WOULD NOT DEPLOY OFF OF THE CATHETER. THE HANDLE WAS EXTENDED ALL THE WAY, PULL WIRES WERE MANIPULATED AND THE SCOPE WAS TAKEN OUT OF RETROFLEXION AND EVENTUALLY, THE CLIP WAS DEPLOYED. THE PROCEDURE WAS COMPLETED AT THIS TIME. IT WAS ALSO NOTED THAT THE CONTROL WIRE BROKE INSIDE OF THE HANDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110626 ↗
• MalfunctionAug 2, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE, BUT FAILED TO RELEASE FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259565 ↗
• MalfunctionJul 13, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE BUT FAILED TO RELEASE FROM THE CATHETER TO DEPLOY. IT WAS NOTED THAT NONE OF THE STAGES OF DEPLOYMENT WERE FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12161395 ↗
• MalfunctionMar 5, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE STOMACH DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS FIRED; HOWEVER, THE CLIP DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793902 ↗
• MalfunctionDec 26, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE, BUT WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520670 ↗
• MalfunctionAug 15, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE BOWEL DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP DEPLOYED INCORRECTLY INSIDE THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8897061 ↗
• MalfunctionJul 30, 2019Detachment of Device or Device Component

  BOSTON SCIENTIFIC RESOLUTION CLIP PASSED THROUGH SCOPE AND WHEN TECH OPENED IT TO PLACE IT OVER THE BLEEDING SITE, ONE FLANGE OF THE CLIP SIMPLY FELL OFF LEAVING THE CLIP UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8840845 ↗
• MalfunctionMar 2, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN A COLONOSCOPY PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO THE TISSUE BUT FAILED TO RELEASE FROM THE CATHETER. THE CLIP WAS FINALLY RELEASED AFTER 15 MINUTES, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 7311286 ↗