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iSnare

US Endoscopy · Model 00711084 · UDI-DI 00724995180782

FDIFBK Prescription
10
510(k) clearances
4,658
Adverse events (10 deaths)
18
Recalls
60
Facilities

Description

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.

Recalls

DateFirmReason
2025-10-06Olympus Corporation of the AmericasSterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
2025-10-06Olympus Corporation of the AmericasSterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
2021-01-19Boston Scientific CorporationPackaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19Boston Scientific CorporationPackaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19Boston Scientific CorporationPackaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2020-07-06Boston Scientific CorporationBSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06Boston Scientific CorporationBSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06Boston Scientific CorporationBSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06Boston Scientific CorporationBSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06Boston Scientific CorporationBSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.