Food, drugs, devices › Edwards Lifesciences, LLC
Device recall: ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Mod
Edwards Lifesciences, LLC (Draper, UT) initiated this device recall on 26 Aug 2015; FDA lists 1 product record under event 72046, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 10 Feb 2017. Initiation: voluntary: firm initiated. Edwards Lifesciences, LLC has 50 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Edwards Lifesciences, LLC, Draper, UT.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2780-2015 | 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… | 759 units | Class II | Terminated | 30 Sep 2015 |
Context
Other enforcement events for Edwards Lifesciences, LLC
All 50 events for Edwards Lifesciences, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Feb 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.