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.
This recall has been terminated (originally issued September 18, 2015).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- August 26, 2015
- Posted
- September 18, 2015
- Terminated
- February 10, 2017
- Recall Number
- Z-2780-2015
- Quantity
- 759 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
Lot / Code Info
Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112
Root Cause
Process control
Action Taken
Edwards sent an Urgent-Product Recall - Action Required letter dated August 26, 2015, to all affected customers. Letters were sent via Fed-Ex. Please check your inventory for the affected Lot Numbers listed above and return the enclosed confirmation form. If your inventory includes affected product, please contact Edwards Lifesciences to obtain an RGA number and return the affected product. We apologize for the inconvenience caused by this action and appreciate your attention to this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Service at (800) 424-3278 from 6:00AM 4:30PM Pacific Time.