FDAAugust 26, 2015device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
edwards lifesciencesedwards
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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