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

Recalled September 30, 2015 · FDA recall Z-2780-2015 · Edwards Lifesciences

Hazard

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. · FDA Class II

Units

759 units

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Edwards Lifesciences, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →