iSnare 00711084 (UDI 00816765012741)Recalls & reported problems
US Endoscopy · The iSnare system–Lariat snare is used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures, and can be used with or without monopolar diathermic energy. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816765012741), received between Dec 14, 2017 and Oct 4, 2019 — classified as 1 injury, 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
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2019Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE SNARE LOOP OF THEIR ISNARE SYSTEM - LARIAT SNARE DETACHED DURING A PATIENT PROCEDURE. THE LOOP WAS RETRIEVED WITH A FORCEPS DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND ISNARE SYSTEM - LARIAT SNARE. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9155761 ↗InjuryDec 14, 2017Device Operates Differently Than Expected
THE USER FACILITY REPORTED INCOMPLETE RESECTION DURING A POLYPECTOMY PROCEDURE WHICH INCLUDED USE OF THE ISNARE LARIAT. FOLLOWING THE POLYPECTOMY A CLIP WAS PLACED AT THE SITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7118344 ↗
Other endoscopic injection needle, gastroenterology-urology devices
- AcuJect G22526Cook Incorporated · endoscopic injection needle, gastroenterology-urology1 recall1 report
- n.a. 27182AKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 35cm DIS199Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- n.a. 27030NKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 70cm DIS201Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology28 reports
- Single Use Injector NM-401L-0423Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology27 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology26 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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