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Polyp Pak

US Endoscopy · Model 00711091 · UDI-DI 00816765010952

FDI Prescription

510(k) clearances

4,640

Adverse events (10 deaths)

Recalls

Facilities

Description

The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotator snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy. The Roth Net retriever is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.

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.