Resolution ClipRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,189
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 2 models of Resolution Clip by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,189 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Aug 31, 2026 — classified as 12 injuries, 1,177 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1,078 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
Reports received per month, all models
Most reported Resolution Clip problems
Device problems
- Activation, Positioning or Separation Problem1,078
- Adverse Event Without Identified Device or Use Problem106
- Difficult to Open or Close103
- Premature Activation80
- Use of Device Problem79
- Material Deformation53
- Break45
- Material Twisted/Bent24
Patient problems
- No Clinical Signs, Symptoms or Conditions632
- No Consequences Or Impact To Patient490
- No Known Impact Or Consequence To Patient51
- Hemorrhage/Blood Loss/Bleeding19
- No Patient Involvement15
- Insufficient Information5
- Unspecified Tissue Injury3
- Discomfort2
Resolution Clip models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Resolution Clip M00522610Hemostatic metal clip for the GI tract1,116 reports
- Resolution Clip M00522600Hemostatic metal clip for the GI tract73 reports
Recent Resolution Clip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Use of Device Problem; Activation, Positioning or Separation Problem; Human-Device Interface Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533775 ↗MalfunctionJun 4, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIPS WERE USED IN THE COLON DURING A COLON SCREENING PROCEDURE. DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE 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. 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 25391414 ↗MalfunctionJun 4, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIPS WERE USED IN THE COLON DURING A COLON SCREENING PROCEDURE. DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE 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. NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391412 ↗MalfunctionMay 18, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPIC ESOPHAGEAL MUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP COULD NOT BE DEPLOYED WHILE IT WAS ENGAGED WITH THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 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 25208759 ↗MalfunctionApr 16, 2026Entrapment of Device; Human-Device Interface Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CLIP WOULD NOT DEPLOY THEN FELL OFF CATHETER WHILE REMOVING FROM SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904655 ↗MalfunctionMar 11, 2026Premature Activation
NOTE: THIS REPORT PERTAINS TO TWO OF THE FIVE RESOLUTION CLIPS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED FOR BLEEDING DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP FELL OFF BEFORE DEPLOYMENT STEPS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567498 ↗MalfunctionMar 11, 2026Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP PREMATURELY DEPLOYED IN UNKNOWN LOCATION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS REPORT PERTAINS TO FOUR OF FIVE CLIPS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567491 ↗MalfunctionMar 10, 2026Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP PREMATURELY DEPLOYED IN UNKNOWN LOCATION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS REPORT PERTAINS TO FIVE OF FIVE CLIPS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561544 ↗MalfunctionMar 10, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CLIP UNABLE TO RELEASE FROM CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. 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 24559680 ↗MalfunctionMar 6, 2026Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP PREMATURELY DEPLOYED IN UNKNOWN LOCATION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS REPORT PERTAINS TO ONE OF FIVE CLIPS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531287 ↗MalfunctionMar 3, 2026Premature Activation
NOTE: THIS REPORT PERTAINS TO THE FIRST OF FIVE RESOLUTION CLIP USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN AN UNKNOWN ANATOMY DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CLIP WOULD DEPLOY BEFORE DEPLOYMENT STEPS WERE TAKEN. THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500187 ↗MalfunctionMar 3, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE STOMACH FOR HEMOSTASIS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP TIP OF THE HANDLE COULD NOT BE DEPLOYED AFTER BEING PUSHED AND PULLED FOR MANY TIMES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND 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 24496396 ↗MalfunctionMar 2, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE INTESTINAL TRACT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WOUND HEMOSTASIS PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP COULD NOT BE DEPLOYED PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 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 STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484144 ↗MalfunctionFeb 24, 2026Activation, Positioning or Separation Problem; Human-Device Interface Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RESOLUTION CLIP COULD NOT BE COMPLETELY DEPLOYED AFTER THE HANDLE WAS PUSHED AND PULLED FOR MANY TIMES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 25, 2026, STATING THAT A POOR BITE OCCURRED, NOT FAILURE TO RELEASE FROM CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428752 ↗MalfunctionFeb 20, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED FOR INTESTINAL POLYPS IN THE INTESTINAL TRACT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR A WOUND HEMOSTASIS PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP COULD NOT BE DEPLOYED PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 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 24406222 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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