MANTIS™ Clip M00521420Recalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 00191506023591), received between Feb 23, 2023 and Sep 29, 2026 — classified as 18 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (147 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 25 most recent of 195 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940797 ↗
• MalfunctionAug 19, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333753 ↗
• InjuryAug 17, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that a MANTIS was used during an Endoscopic Submucosal Dissection (ESD) procedure performed on (b)(6) 2026.During the procedure, parts of the metal fittings detached and were removed endoscopically. The anatomy location is unknown. The procedure was completed with the original device. There were no patient complications or adverse events reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288793 ↗
• MalfunctionAug 14, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255901 ↗
• MalfunctionJul 20, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876940 ↗
• MalfunctionJul 15, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS TO BE USED DURING AN UNKNOWN GASTROENTEROLOGY PROCEDURE ON (B)(6) 2026. UPON REMOVAL FROM THE PACKAGING, A MANTIS CLIP SPONTANEOUSLY DETACHED AND DEPLOYED IN AN OPEN POSITION OUTSIDE OF THE PATIENT. THE CLIP WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE CLIP WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829121 ↗
• MalfunctionJul 2, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS WAS USED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE FOURTH CLIP WAS DIFFICULT TO RELEASE FROM THE CATHETER. AFTER SEVERAL ATTEMPTS THE CLIP WAS ABLE TO BE 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689915 ↗
• MalfunctionMay 14, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN ATTEMPTING TO CLOSE THE DEVICE, IT WAS UNABLE TO RELEASE THE CLIP DESPITE PRODUCING THE NORMAL RELEASE SOUND. THE CLIP BECAME STUCK AND HAD TO BE FORCIBLY REMOVED. THE WOUND DID NOT REOPEN; HOWEVER, THE DEFECT WAS NOT SUCCESSFULLY CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANTIS CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176416 ↗
• MalfunctionMay 13, 2026Positioning Failure; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED DURING A PROCEDURE ON (B)(6) 2026, TO CLOSE A STOMACH FISTULA. IT WAS REPORTED THAT DURING THE PROCEDURE, THE MANTIS CLIP ARM BROKE OFF WHICH DID NOT ALLOW PROPER DEPLOYMENT. THE MANTIS CLIP WAS RELEASED INSIDE THE PATIENT DUE TO THE INABILITY TO REMOVE IT THROUGH THE ENDOSCOPE WORKING CHANNEL. THE PROCEDURE WAS RESCHEDULED AS THEY DID NOT HAVE BACKUP DEVICES TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164848 ↗
• MalfunctionMay 8, 2026Activation, 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 MANTIS CLIP WAS USED DURING A COLON ESD PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE MANTIS CLIP DID NOT DETACH FROM THE SHEATH. THE PHYSICIAN ATTEMPTED TO RETRACT AND EXTEND THE SHEATH SEVERAL TIMES. AFTER A FEW ATTEMPTS, THE SHEATH AND CLIP DETACHED; HOWEVER, THE MANTIS ALSO DISENGAGED FROM THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO OTHER REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126272 ↗
• MalfunctionApr 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON APRIL 14, 2026. DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THERE WAS NO PATIENT INJURY. 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 25046231 ↗
• MalfunctionMar 31, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE PHYSICIAN AND TECH TRIED TO TROUBLESHOOT BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO CLIPS USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742511 ↗
• MalfunctionMar 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP DEVICE WAS USED IN THE ASCENDING 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; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. IT WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANTIS CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732839 ↗
• MalfunctionMar 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE PHYSICIAN AND TECH TRIED TO TROUBLESHOOT BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714857 ↗
• MalfunctionMar 25, 2026Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CLIP RELEASED WITHOUT SQUEEZING TO DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689102 ↗
• MalfunctionMar 25, 2026Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT AFTER GRABBING ONE SIDE OF RESECTION, WHEN REOPENED TO GRAB TISSUE TO CLOSE, ONE-HALF OF THE CLIP FELL OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689092 ↗
• MalfunctionMar 24, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED DURING AN ENDOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE MANTIS CLIP LOCKED ONTO TISSUE, BUT THE HANDLE AND SPRING WIRE BROKE, AND MANIPULATION OF MOVING LEFT AND RIGHT, TRYING TO REPOSITION CATHETER, TRYING TO BEND TO ANGLE AND PULL TRYING TO TORQUE TO GET THE CLIP TO RELEASE. THE CLIP ULTIMATELY WAS RELEASED AFTER A REPORTED 20 MINUTES OF MANIPULATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO CLIPS USED IN DIFFERENT PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682047 ↗
• MalfunctionMar 20, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED DURING AN ENDOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE MANTIS CLIP LOCKED ONTO TISSUE, BUT THE HANDLE AND SPRING WIRE BROKE, AND MANIPULATION OF MOVING LEFT AND RIGHT, TRYING TO REPOSITION CATHETER, TRYING TO BEND TO ANGLE AND PULL TRYING TO TORQUE TO GET THE CLIP TO RELEASE. THE CLIP ULTIMATELY WAS RELEASED AFTER A REPORTED 20 MINUTES OF MANIPULATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO CLIPS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647577 ↗
• MalfunctionMar 9, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMICAL LOCATION IS UNKNOWN. DURING THE PROCEDURE, THE CLIP WAS RELEASED WITHOUT ANY ACTION TAKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552633 ↗
• MalfunctionMar 9, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MANTIS CLIPS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIPS WERE DIFFICULT TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL 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 TWO OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544705 ↗
• MalfunctionMar 5, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MANTIS CLIP WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIPS WERE DIFFICULT TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL 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 ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520172 ↗
• MalfunctionMar 3, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS CLIP WAS USED DURING AN ESD PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE MANTIS CLIP WAS HARD TO RELEASE AND AFTER MOVING THE CATHETER MULTIPLE TIMES, THE CLIP ULTIMATELY WAS ABLE TO BE RELEASED. 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 24498128 ↗
• MalfunctionFeb 26, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE HANDLE WAS OPENED AND CLOSED MULTIPLE TIMES TO REMOVE THE CLIP BUT WAS UNSUCCESSFUL. THE PHYSICIAN MANUALLY BROKE THE HANDLE AND PULLED THE CONTROL WIRE FROM THE HANDLE TO RELEASE THE CLIP. THE PROCEDURE WAS COMPLETED WITH 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456770 ↗
• MalfunctionFeb 25, 2026Premature Activation; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MANTIS WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE MANTIS FAILED TO DEPLOY; IT WAS CONFIRMED THAT THE CLIP UNABLE TO GRASP/CLOSE ONTO TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANTIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CLIP PREMATURE DEPLOYMENT AT AN UNKNOWN ANATOMY LOCATION. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445867 ↗
• MalfunctionFeb 20, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MANTIS CLIPS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE HANDLE SPRINGS POPPED OUT AND PREVENTED THE CLIPS FROM DEPLOYING. THE PROCEDURE WAS COMPLETED WITH UNKNOWN DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE UNKNOWN. NOTE: THIS REPORT PERTAINS TO ONE 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 24400557 ↗