SureClip(®) Repositionable Hemostasis Clip ROCC-D-26-235-C-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06932503530446), received between Jun 11, 2025 and Jun 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Unintended Movement; Firing Problem; Unintended Movement; Firing Problem

  IT WAS REPORTED THAT PATIENT PRESENTED TO ENDOSCOPY DEPARTMENT AS A TRANSFER FROM INTENSIVE CARE FOR AN EGD [ESOPHAGOGASTRODUODENOSCOPY] COLONOSCOPY FOR GIB [GASTROINTESTINAL BLEEDING]. UPON ENTERING STOMACH WITH ENDOSCOPE, PATIENT'S STOMACH WAS FOUND TO CONTAIN OLD BLOOD AND FOOD DEBRIS, WHICH WERE REMOVED. UPON ADVANCING FURTHER, PATIENT'S DUODENAL BULB WAS FOUND TO CONTAIN A LARGE ULCER WITH A VISIBLE BLOOD VESSEL (NOT ACTIVELY BLEEDING). EPINEPHRINE WAS INJECTED INTO ULCER, FOLLOWED BY ELECTROCAUTERY BEING ADMINISTERED. ONE HEMOSTASIS CLIP WAS DEPLOYED WITH NO PROBLEM, BUT THE SECOND CLIP MIS-DEPLOYED. AFTER THIS, BLOOD BEGAN TO STREAM OUT OF ULCER. VARIOUS METHODS OF TREATMENT WERE USED UNTIL HEMOSTASIS WAS ACHIEVED. GI CALLED CVIR [CARDIOVASCULAR INTERVENTIONAL RADIOLOGY] DEPARTMENT TO ALERT THEM OF SITUATION AND MAKE SURE THEY WERE READY TO TAKE PATIENT FOR EMBOLIZATION. PATIENT REMAINED INTUBATED AND WAS TRANSPORTED FROM ENDOSCOPY TO CVIR WITH THIS RN, ANESTHESIA RESIDENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 22295899 ↗
• MalfunctionJun 11, 2025Difficult to Advance

  PATIENT PRESENTED TO ENDOSCOPY DEPARTMENT AS A TRANSFER FROM INTENSIVE CARE FOR AN EGD [ESOPHAGOGASTRODUODENOSCOPY] COLONOSCOPY FOR GIB [GASTROINTESTINAL BLEEDING]. UPON ENTERING STOMACH WITH ENDOSCOPE, PATIENT'S STOMACH WAS FOUND TO CONTAIN OLD BLOOD AND FOOD DEBRIS, WHICH WERE REMOVED. UPON ADVANCING FURTHER, PATIENT'S DUODENAL BULB WAS FOUND TO CONTAIN A LARGE ULCER WITH A VISIBLE BLOOD VESSEL (NOT ACTIVELY BLEEDING). EPINEPHRINE WAS INJECTED INTO ULCER, FOLLOWED BY ELECTROCAUTERY BEING ADMINISTERED. ONE HEMOSTASIS CLIP WAS DEPLOYED WITH NO PROBLEM, BUT THE SECOND CLIP MIS-DEPLOYED. AFTER THIS, BLOOD BEGAN TO STREAM OUT OF ULCER. VARIOUS METHODS OF TREATMENT WERE USED UNTIL HEMOSTASIS WAS ACHIEVED. GI CALLED CVIR [CARDIOVASCULAR INTERVENTIONAL RADIOLOGY] DEPARTMENT TO ALERT THEM OF SITUATION AND MAKE SURE THEY WERE READY TO TAKE PATIENT FOR EMBOLIZATION. PATIENT REMAINED INTUBATED AND WAS TRANSPORTED FROM ENDOSCOPY TO CVIR WITH THIS RN, ANESTHESIA RESIDENT. UDI-DI NUMBER: (01)06932503530446(17)270616(10)M240617231

  Patient problems: Embolism/Embolus; Gastrointestinal Hemorrhage; Stomach Ulceration

  MAUDE report 22183365 ↗