Assurance 00711885Recalls & reported problems
US Endoscopy · The Assurance Clip - 18 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 00724995219154), received between Oct 4, 2024 and Apr 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Fell1
- Failure to Fire1
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.
MalfunctionApr 14, 2026Failure to Fire; Detachment of Device or Device Component
THE USER FACILITY REPORTED WHILE USING THEIR ASSURANCE CLIP DURING A PATIENT PROCEDURE THAT THE CLIP WAS ONLY ABLE TO PARTIALLY DEPLOY. WHILE ATTEMPTING TO FULLY DEPLOY THE CLIP, THE CLIP'S INSIDE METAL HOOK DETACHED AND FELL INTO THE PATIENT. THE PIECES OF THE METAL HOOK WERE RETRIEVED AND THE PATIENT RECEIVED X-RAYS THAT CONFIRMED NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875516 ↗MalfunctionMar 5, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A PIECE OF WIRE FROM THEIR ASSURANCE CLIP WAS PROTRUDING FOLLOWING DEPLOYMENT. THE WIRE WAS REMOVED FROM THE PATIENT TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523663 ↗MalfunctionOct 4, 2024Device Fell; Device Fell
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE TWO ASSURANCE CLIPS FELL OFF THE DEVICE INTO THE PATIENT. THE CLIPS HAD TO BE RETRIEVED USING A NET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER ASSURANCE CLIP. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368173 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page