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Recall Observatory FDA recall evidence

Device 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.

Z-2780-2015

August 26, 2015

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 72046
Status
Terminated
Classification
Class II
Quantity
759 units
Official record key
device-enforcement:Z-2780-2015

Official wording

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.

Code information: Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112

Distribution pattern: Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.