FDA Device recall Z-2780-2015
ThruPort Knot Pusher
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of ThruPort Knot Pusher by Edwards Lifesciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2780-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-26 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2780-2015%22
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