Recall Z-2780-2015— Edwards Lifesciences, LLC
Class II · Terminated
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2015-08-26, terminated 2017-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-26
- Terminated
- 2017-02-10
- Firm location
- Draper, UT, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.