FDA-Device2015-09-30Class II
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.
Edwards Lifesciences, LLC
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.
Sold states
Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
Affected count
759 units
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2780-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief