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RETENTIA Hemoclip

Yangzhou Fartley Medical Instrument Technology Co., Ltd · Model FTL-HC-12-230-O · UDI-DI 06936603218211

PKL Prescription

510(k) clearances

7,363

Adverse events (25 deaths)

Recalls

Facilities

Description

Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 230cm, 12mm clip length

Recalls

Date	Firm	Reason
2026-03-03	Wilson-Cook Medical Inc.	Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2019-02-04	US Endoscopy Group Inc	Potential esophageal laceration during a patient procedure

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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.