iSnare 00711086 (UDI 00816765010921)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 00816765010921), received between Nov 30, 2018 and Nov 30, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2018Physical Resistance/Sticking
THE USER FACILITY REPORTED THE ISNARE DEVICE FAILED TO COMPLETE THE RESECTION OF A LARGE POLYP, AND THAT THE USER WAS UNABLE TO DISENGAGE THE SNARE LOOP FROM THE POLYP. THE USER REPORTED A PROCEDURAL DELAY RESULTED FROM FREEING THE SNARE LOOP FROM THE POLYP WITH A FORCEPS DEVICE. THE POLYP RESECTION WAS FINISHED WITH ANOTHER SNARE AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8120180 ↗
Other SNARE, FLEXIBLE devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.