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SINGULAR

Conmed Corporation · Model 000980 · UDI-DI 10653405053293

FDI Prescription

510(k) clearances

4,640

Adverse events (10 deaths)

Recalls

Facilities

Description

SINGULAR Polypectomy Snare; Large Oval Loop, Soft Wire, Microvasive Connector

Recalls

Date	Firm	Reason
2025-10-06	Olympus Corporation of the Americas	Sterility 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.
2025-10-06	Olympus Corporation of the Americas	Sterility 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.
2021-01-19	Boston Scientific Corporation	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19	Boston Scientific Corporation	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19	Boston Scientific Corporation	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2020-07-06	Boston Scientific Corporation	BSC 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
2020-07-06	Boston Scientific Corporation	BSC 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
2020-07-06	Boston Scientific Corporation	BSC 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
2020-07-06	Boston Scientific Corporation	BSC 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
2020-07-06	Boston Scientific Corporation	BSC 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.