FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: 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.
- Recall number
- Z-2780-2015
- Recalling firm
- Edwards Lifesciences, LLC
- 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.
- Status
- Terminated
- Initiated
- 2015-08-26
- Posted
- 2015-09-18
- Terminated
- 2017-02-10
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 759 units
- Distribution
- Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
- Lot, serial or model codes
- Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DPT
- Firm FEI
- 1713910
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28