FDAMay 4, 2023device

Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170385933

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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