DuraClip(TM) Repositionable Hemostasis Clip DC0235Recalls & reported problems
Transmed (China) Co., Ltd. · Open width11±1mm the max OD of insertion part2.6mm working length2350mm coated · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 16932619740019), received between Dec 10, 2024 and Sep 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Mechanics Altered1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Mechanics Altered
It was reported that the clip deployment malfunctioned and the clip did not catch tissue. The original intended procedure was EGD (ENDO) ESOPHAGOGASTRODUODENOSCOPY W/CONTROL OF BLEEDING ANY TYPE. Therapies being used on the patient at the time of the event that may have caused or contributed to the event: Not applicable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877509 ↗MalfunctionSep 17, 2026Activation Failure
Deployment malfunctioned; did not catch tissue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801601 ↗MalfunctionDec 10, 2024Use of Device Problem; Use of Device Problem
THE CUSTOMER PLACED AN EXPIRED DURA CLIP INTO THE PATIENT. THE CLIP WORKED CORRECTLY AND WAS CONTROLLING THE BLEEDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20890955 ↗
Other Hemostatic Metal Clip For The Gi Tract devices
- Resolution 360 Clip M00521230Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths2,291 reports
- Resolution Clip M00522610Boston Scientific Corporation · Hemostatic metal clip for the GI tract1,116 reports
- Instinct G58010Cook Incorporated · Hemostatic metal clip for the GI tract1 recall1,017 reports
- Resolution 360™ ULTRA Clip M00521400Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths496 reports
- Instinct G18343Cook Incorporated · Hemostatic metal clip for the GI tract244 reports
- MANTIS™ Clip M00521420Boston Scientific Corporation · Hemostatic metal clip for the GI tract195 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract1 recall118 reports
- colonic FTRD Set 14Ovesco Endoscopy AG · Hemostatic Metal Clip For The Gi Tract2 deaths95 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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