ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Mod

FDA device recall Z-2780-2015 · posted 2015-09-18 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

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.

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.

Root cause

Process control

Status

Terminated

Product code

DPT

Quantity affected

759 units

Distribution

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

Date initiated

2015-08-26

Date posted

2015-09-18

Date terminated

2017-02-10

Location

Draper, UT