Assurance 00711884Recalls & reported problems
US Endoscopy · The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation. · Class 2 · Implant
Data updated Oct 16, 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 00724995215804), received between Sep 27, 2023 and Sep 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
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 25, 2026Detachment of Device or Device Component
The user facility reported that during a patient procedure following the deployment of their Assurance Clip, a metal piece from the device ¿fell off into the colon¿. The piece was retrieved and the patient procedure was completed successfully. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895595 ↗MalfunctionAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, METAL PIECES FROM THE ASSURANCE CLIP FOLLOWING DEPLOYMENT WERE FOUND WITHIN THE PATIENT. THE FACILITY UTILIZED A SUCTION DEVICE TO REMOVE THE PIECES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751169 ↗MalfunctionSep 27, 2023Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE JAW ARM BECAME DETACHED FROM THE DISTAL END OF THE ASSURANCE CLIP DEVICE. FORCEPS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY, BUT THERE WAS A SLIGHT PROCEDURE DELAY REPORTED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17827530 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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