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Padlock Clip

US Endoscopy · Model 00713229 · UDI-DI 00724995226732

FDI KNS PKL Prescription

510(k) clearances

4,658

Adverse events (10 deaths)

Recalls

Facilities

Description

The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and TouchSoft Coagulator Probe. It is designed for use in a flexible endoscope intended for the diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.

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.