iSnare 00711088Recalls & reported problems
US Endoscopy · The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00724995180812), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.
Most reported problems
Device problems
- Physical Resistance/Sticking1
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.
MalfunctionFeb 18, 2021Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE SNARE LOOP OF AN ISNARE SYSTEM - HEXAGONAL SNARE BECAME STUCK ON A POLYP DURING PROCEDURAL USE. THE USER FACILITY REPORTED THAT AN ADDITIONAL SNARE WAS USED TO FREE THE SNARE LOOP AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED HARM TO THE PATIENT OR USER OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11344281 ↗
Other SNARE, FLEXIBLE devices
- CAPTIFLEX M00562400Boston Scientific Corporation · SNARE, FLEXIBLE3 recalls85 reports
- SENSATION Short Throw M00562670Boston Scientific Corporation · SNARE, FLEXIBLE1 recall178 reports
- SENSATION Short Throw M00562650Boston Scientific Corporation · SNARE, FLEXIBLE1 recall173 reports
- Ultratome XL M00535900Boston Scientific Corporation · SNARE, FLEXIBLE205 reports
- CAPTIVATOR M00562340Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls71 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls32 reports
- CAPTIVATOR M00562300Boston Scientific Corporation · SNARE, FLEXIBLE1 recall78 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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