Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2015-08-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2780-2015
Date of alert
2015-08-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Edwards Lifesciences, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
59964698
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.