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iSnare 00711086 (UDI 00724995180805)Recalls & reported problems

US Endoscopy · The iSnare oval system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995180805), received between Mar 7, 2021 and Mar 7, 2021 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 7, 2021Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT THE SNARE LOOP OF AN ISNARE SYSTEM - OVAL SNARE DETACHED FROM THE DEVICE DURING PROCEDURAL USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SNARE AND THE DETACHED COMPONENT WAS RETRIEVED. THERE WAS NO REPORTED HARM TO THE PATIENT OR USER OF THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11426767 ↗

Other endoscopic injection needle, gastroenterology-urology devices

All endoscopic injection needle, gastroenterology-urology devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.