Resolution 360™ ULTRA Clip M00521400Recalls & reported problems

Summary

The FDA's MAUDE database contains 496 adverse event reports that list this exact device (DI 08714729997245), received between Nov 2, 2020 and Sep 29, 2026 — classified as 3 deaths, 11 injuries, 482 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (376 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 496 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933394 ↗
• MalfunctionSep 23, 2026Activation, Positioning or Separation Problem

  It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during an unknown procedure on (b)(6) 2026.During the procedure, the Resolution 360 Clip would not disengage from the catheter after several attempts and excessive maneuvering was required for approximately one minute to get the clip to deploy appropriately. There were no reported patient complications. The procedure was completed with the same device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869030 ↗
• MalfunctionSep 17, 2026Premature Activation

  It was reported to Boston Scientific Corporation that a Resolution 360 Ultra Clip was used during a mucosectomy at an unknown anatomical location in a procedure performed on (b)(6) 2026. During the procedure, while the clip was being positioned, it detached without having been released. The procedure was completed. No information regarding how the procedure was completed was provided.There were no reported patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803765 ↗
• MalfunctionSep 10, 2026Activation, Positioning or Separation Problem

  It was reported to Boston Scientific Corporation that a Resolution 360 Ultra Clip was used in the colon during a colonoscopy procedure performed on (b)(6) 2026 for the treatment of polyps.During the procedure, the clips were able to lock and grasp onto tissue but difficult to deploy. There were no kinks in noticed in the catheters. The physician had to open and close their hand multiple times, and they tried to maneuver the inner wire. They ended up pulling the clip to get the clip to detach and it stayed on the mucosa. The procedure was completed with the original device as intended. The second clip was difficult to deploy. The clip was able to detach after opening and closing the handle multiple times. The procedure was completed with the original device as intended. 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.Note: This report pertains to the first of two devices used during the same procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716039 ↗
• MalfunctionSep 3, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599512 ↗
• MalfunctionAug 21, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380874 ↗
• MalfunctionJul 22, 2026Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25903234 ↗
• MalfunctionJul 20, 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 was used in the colon during a colonoscopy procedure performed on (b)(6) 2026 for the treatment of gastrointestinal bleed.During the procedure, the clip was able to grasp and lock onto the tissue but failed to release from the catheter. There was no kinks noticed in the catheter. They tried to open of the handle, and it would not release. The procedure was completed with another of the same 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 fully recovered.Additional Information received:No tissue damage was generated since the clip did not deploy to the tissue.This report pertained to one of two devices used during the same procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876964 ↗
• MalfunctionJul 7, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE FOR POLYPS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP CLOSED AND LOCKED ONTO TISSUE BUT FAILED TO RELEASE FROM THE CATHETER. OPENING AND CLOSING OF THE HANDLE AND PULLING THE CATHETER WAS ABLE TO REMOVE THE CLIP FROM THE SCOPE WHILE STILL ATTACHED TO THE CATHETER. THERE WAS NO DAMAGE TO PATIENT TISSUE WHEN CLIP WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740359 ↗
• DeathJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE FOR TREATMENT OF A POSSIBLE GASTROINTESTINAL BLEED. NOTE: THREE RESOLUTION 360 ULTRA CLIPS WERE USED IN THE SAME ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE. ADDITIONALLY, THE SAME PATIENT SUBSEQUENTLY UNDERWENT AN ADDITIONAL SURGERY ON AN UNKNOWN DATE. DURING THE PROCEDURE, AFTER SUCCESSFUL PLACEMENTS OF TWO RESOLUTION 360 ULTRA CLIPS, A THIRD RESOLUTION 360 ULTRA CLIP WAS USED AND BLEEDING WAS NOTED TO HAVE STARTED. THE PATIENT BECAME HYPOTENSIVE AND THE PATIENT WENT INTO A DIC AND WAS ADMITTED TO THE ICU WHERE THE PATIENT LATER DIED ON AN UNKNOWN DATE. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT AN UNKNOWN ADDITIONAL SURGERY OCCURRED AS A RESULT OF THE PROCEDURE. NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE RESOLUTION 360 CLIPS USED DURING THE SAME ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED A PATIENT COMPLICATION OF HYPOTENSION LEADING TO DIC WITH AN OUTCOME OF DEATH ON AN UNKNOWN DATE. THE EXTENT OF THE IMPACT, IF ANY, OF THE PROCEDURE OR RESOLUTI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 25690793 ↗
• DeathJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE FOR TREATMENT OF A POSSIBLE GASTROINTESTINAL BLEED. NOTE: THREE RESOLUTION 360 ULTRA CLIPS WERE USED IN THE SAME ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE. ADDITIONALLY, THE SAME PATIENT SUBSEQUENTLY UNDERWENT AN ADDITIONAL SURGERY ON AN UNKNOWN DATE. DURING THE PROCEDURE, AFTER SUCCESSFUL PLACEMENTS OF TWO RESOLUTION 360 ULTRA CLIPS, A THIRD RESOLUTION 360 ULTRA CLIP WAS USED AND BLEEDING WAS NOTED TO HAVE STARTED. THE PATIENT BECAME HYPOTENSIVE AND THE PATIENT WENT INTO A DIC AND WAS ADMITTED TO THE ICU WHERE THE PATIENT LATER DIED ON AN UNKNOWN DATE. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT AN UNKNOWN ADDITIONAL SURGERY OCCURRED AS A RESULT OF THE PROCEDURE. NOTE: THIS MEDICAL DEVICE REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION AS THERE IS NO ALLEGED MALFUNCTION WITH THE RESOLUTION 360 ULTRA CLIP. THIS REPORT PERTAINS TO THE FIRST OF THREE RESOLUTION 360 ULTRA CLIPS THAT WERE USED DURING THE SAME ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON UNKNOWN DATE. IT WAS REPORTED A PATIE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 25690785 ↗
• DeathJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE FOR TREATMENT OF A POSSIBLE GASTROINTESTINAL BLEED. NOTE: THREE RESOLUTION 360 ULTRA CLIPS WERE USED IN THE SAME ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON AN UNKNOWN DATE. ADDITIONALLY, THE SAME PATIENT SUBSEQUENTLY UNDERWENT AN ADDITIONAL SURGERY ON AN UNKNOWN DATE. DURING THE PROCEDURE, AFTER SUCCESSFUL PLACEMENTS OF TWO RESOLUTION 360 ULTRA CLIPS, A THIRD RESOLUTION 360 ULTRA CLIP WAS USED AND BLEEDING WAS NOTED TO HAVE STARTED. THE PATIENT BECAME HYPOTENSIVE AND THE PATIENT WENT INTO A DIC AND WAS ADMITTED TO THE ICU WHERE THE PATIENT LATER DIED ON AN UNKNOWN DATE. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT AN UNKNOWN ADDITIONAL SURGERY OCCURRED AS A RESULT OF THE PROCEDURE. NOTE: THIS MEDICAL DEVICE REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION AS THERE IS NO ALLEGED MALFUNCTION WITH THE RESOLUTION 360 ULTRA CLIP. THIS REPORT PERTAINS TO THE SECOND OF THREE RESOLUTION 360 ULTRA CLIPS THAT WERE USED DURING THE SAME ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON UNKNOWN DATE. IT WAS REPORTED A PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 25690782 ↗
• MalfunctionJun 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE FOR POLYPS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP WAS UNABLE TO DETACH FROM THE CATHETER. EVENTUALLY, THE CATHETER WAS PULLED BACK AND THE CLIP DETACHED. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673416 ↗
• MalfunctionJun 25, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP DEVICE WAS USED FOR SCREENING DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP WOULD NOT DEPLOY FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 ULTRA CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627527 ↗
• MalfunctionJun 16, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING A LARGE POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP DEPLOYED IN THE OPEN POSITION. THE ANATOMY LOCATION IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A RESOLUTION 360 CLIP. 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 FULLY RECOVERED. NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522810 ↗
• MalfunctionJun 15, 2026Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE RESOLUTION 360 ULTRA CLIPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE, ON AN UNKNOWN ANATOMY. DURING THE PROCEDURE, DIFFICULTY WAS OBSERVED IN DETACHING THE CLIP FROM THE CATHETER. 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 25498608 ↗
• MalfunctionJun 15, 2026Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO THE ONE OF THREE RESOLUTION 360 ULTRA CLIPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE, ON AN UNKNOWN ANATOMY. DURING THE PROCEDURE, DIFFICULTY WAS OBSERVED IN DETACHING THE CLIP FROM THE CATHETER. 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 25498598 ↗
• MalfunctionJun 9, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE, ON AN UNKNOWN ANATOMY. DURING THE PROCEDURE, DIFFICULTY WAS OBSERVED IN DETACHING THE CLIP FROM THE CATHETER. 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 25445436 ↗
• MalfunctionJun 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 ULTRA CLIP WAS USED DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2026 FOR TREATMENT OF BLEEDING. DURING THE PROCEDURE, THE RESOLUTION 360 ULTRA CLIP WOULD NOT COME OFF OF THE CATHETER WHEN THE NURSE RELEASED THE CLIP. 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 25391463 ↗
• MalfunctionMay 12, 2026Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED AT UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLIP SPRING IN THE HANDLE BROKE WHILE THE CLIP WAS BEING PLACED, AND THE CLIP SUBSEQUENTLY DETACHED FROM THE CATHETER. 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 25150215 ↗
• MalfunctionMay 6, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING A COLONOSCOPY PROCEDURE, FOR THE TREATMENT OF POLYPS, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP DID NOT COME OFF THE CATHETER WHEN TRIED TO BE RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 ULTRA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 25090431 ↗
• MalfunctionMay 4, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE RESOLUTION 360 ULTRA CLIP HAD DIFFICULTY DISENGAGING FROM THE DEVICE AFTER DEPLOYMENT. IT WAS ALSO NOTED THAT THE DEVICE HANDLE SPRING WAS BENT AND BROKEN, AND AFTER A MINUTE OF MANIPULATION, THE PHYSICIAN WAS ABLE TO GET THE DEPLOYED CLIP TO SEPARATE FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH 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 25072761 ↗
• MalfunctionApr 29, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 DURING THE PROCEDURE, THE CLIP WAS DIFFICULT RELEASE FROM THE CATHETER AND REMAINED ATTACHED TO THE GUIDE. THE PROCEDURE WAS COMPLETED WITH UNKNOWN DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029002 ↗
• MalfunctionApr 28, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2026 FOR POLYP REMOVAL. DURING THE PROCEDURE, THE RESOLUTION 360 ULTRA CLIP WOULD NOT RELEASE DURING ATTEMPTED DEPLOYMENT. 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 25017806 ↗
• MalfunctionApr 23, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 ULTRA CLIP WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2026, FOR TREATMENT OF POLYPS. DURING THE PROCEDURE, THE RESOLUTION 360 ULTRA CLIP LOCKED ONTO THE TISSUE BUT WOULD NOT RELEASE FROM THE CATHETER, AND THEY CUT THE HANDLE OFF THE CLIP. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO CLIPS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969017 ↗