Edwards Lifesciences, LLC recalls ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Mo…

Recall date

August 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2780-2015

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.

Why it was recalled

The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.