ThruPort Knot Pusher — Class II medical device recall Z-2780-2015
Terminated recall by Edwards Lifesciences, LLC, reported 2015-09-30, distributed nationwide. The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or split
| Recall number | Z-2780-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2015-08-26 |
| Classified | 2015-09-18 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 759 units |
| Lot numbers | 59964698, 59967596, 59984375, 60016312, 60022521, 60022522, 60045801, 60045802, 60059982, 60064112, 60066591, 60089865 |
| Model numbers | KP1 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2780-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.