Z-2780-2015Class II

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

Name: Z-2780-2015 ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve...
Creator: Edwards Lifesciences, LLC
Published: 2015-08-26
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2015-08-26 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and... on 2015-08-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2780-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-26
Posted: 2015-09-18
Terminated: 2017-02-10
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.
Product code: DPT Probe, Blood-Flow, Extravascular
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 759 units
Distribution: Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
Product codes and lots: Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2780-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2780-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18

Product code DPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)