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.
Reported: September 30, 2015 Initiated: August 26, 2015 #Z-2780-2015
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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 759 units
- Distribution
- Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
- Location
- Draper, UT
Frequently Asked Questions
What product 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.. Recalled by Edwards Lifesciences, LLC. Units affected: 759 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2015. Severity: Moderate. Recall number: Z-2780-2015.
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