DuraClip(TM) Repositionable Hemostasis Clip DC0235WRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 16932619740033), received between Oct 2, 2019 and Feb 13, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Positioning Failure; Separation Problem; Positioning Failure; Separation Problem

  ON JANUARY 29, 2025. TRANSMED RECEIVED A MDR REPORT NOTIFICATION REGARDING DURACLIP FROM FDA. UF/IMPORTER REPORT#: (B)(4). IT WAS REPORTED THAT DEVICE FAILED (BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). TISSUE CLIP MISFIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372046 ↗
• MalfunctionFeb 13, 2025Positioning Failure; Separation Problem; Positioning Failure; Separation Problem

  ON JANUARY 29, 2025. MICRO-TECH RECEICED AN INCIDENT REGARDING DURACLIP FROM TRANSMED (CHINA) CO., LTD. IT WAS REPORTED THAT DEVICE FAILED (BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) , TISSUE CLIP MISFIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372037 ↗
• MalfunctionJan 29, 2025

  TISSUE CLIP MISFIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263101 ↗
• MalfunctionNov 13, 2024

  DURACLIP DID NOT DEPLOY, AND THE END OF IT CAME OFF AFTER THE DEVICE WAS REMOVED FROM THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673890 ↗
• MalfunctionSep 29, 2024Device Fell; Device Fell

  DR. (B)(6) DID A GPOEM LAST WEEK AND THE PATIENT ENDED UP NEEDING A SECOND PROCEDURE DUE TO ALMOST ALL OF THE CLIPS FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20329567 ↗
• MalfunctionSep 25, 2024Firing Problem; Firing Problem

  TWO DURACLIPS MALFUNCTIONED DURING THE CLOSING OF A POST SPHINCTEROTOMY BLEED. THE PHYSICIAN COMPLAINED THAT THE CLIP MALFUNCTION MADE THE BLEEDING WORSE. HE ALSO MENTIONED THAT THE ENDO TECH WAS EXPERIENCED, AND THE SCOPE WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20299446 ↗
• MalfunctionAug 29, 2024Failure to Fire; Failure to Fire

  MICRO-TECH RECEIVED A MDR NOTIFICATION REGARDING DURACLIP FROM FDA ON AUGUST 21, 2024. UF REPORT #:(B)(4). IT WAS REPORTED THAT "ATTEMPTED TO DEPLOY DURACLIP DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) AND CLIP WAS JAMMED AND WOULD NOT DEPLOY. DEPLOYMENT DEVICE REMOVED FROM PATIENT AND SCOPE WITH CLIP STILL ATTACHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20093788 ↗
• MalfunctionAug 20, 2024Mechanical Jam; Activation Failure

  ATTEMPTED TO DEPLOY DURACLIP DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) AND CLIP WAS JAMMED AND WOULD NOT DEPLOY. DEPLOYMENT DEVICE REMOVED FROM PATIENT AND SCOPE WITH CLIP STILL ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 20001526 ↗
• MalfunctionJan 20, 2021Material Fragmentation; Material Fragmentation

  VOLUNTARY DISTRIBUTOR REPORT. THE CUSTOMER REPORTED THAT THE DEVICE, DC0235W, DURACLIP HEMOCLIP, 235CM, 16MM WAS BEING USED DURING A POLYPECTOMY ON (B)(6) 2020 WHEN IT WAS DISCOVERED THAT "TIP FELL OFF IN SCOPE DURING SURGERY". AFTER FURTHER ASSESSMENT QUESTIONING, IT WAS FOUND THAT THE FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT DUE TO THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202473 ↗
• MalfunctionOct 21, 2019Material Fragmentation

  IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED A 16MM DURACLIP AND AFTER DEPLOYMENT A METAL FRAGMENT WAS FOUND IN THE PATIENTS COLON. THE FRAGMENT IS BELIEVED TO BE FROM THE CLIP OR DEVICE DRIVER. THE FRAGMENT WAS MAYBE A MILLIMETER. THEY DID NOT REMOVE THE FRAGMENT. THERE WERE NO ISSUES WITH THE CLIP PRE-PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9216704 ↗
• InjuryOct 2, 2019Material Fragmentation; Material Fragmentation

  VOLUNTARY DISTRIBUTOR REPORT. ON BEHALF OF THE CUSTOMER, THE CONMED SALES REP REPORTED AN ISSUE WITH THE DC0235W, DURACLIP HEMOCLIP, LOT # M190622231 THAT OCCURRED (B)(6) 2019 DURING A COLONOSCOPY AT (B)(6). IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED A 16MM DURACLIP AND AFTER DEPLOYMENT A METAL FRAGMENT WAS FOUND IN THE PATIENTS COLON. THE FRAGMENT IS BELIEVED TO BE FROM THE CLIP OR DEVICE DRIVER. THE FRAGMENT WAS MAYBE A MILLIMETER. THEY DID NOT REMOVE THE FRAGMENT. THERE WERE NO ISSUES WITH THE CLIP PRE-PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THERE WAS FRAGMENTATION, THAT MAY HAVE BEEN FROM THE APPLIER, THAT WAS NOT REMOVED FROM THE PATIENT AT THE TIME OF SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9145088 ↗