—#139667

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.

FDA product code: DPT — Probe, Blood-Flow, Extravascular
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.

Timeline

Recall initiated: 2015-08-26
Posted by FDA: 2015-09-18
Terminated: 2017-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.