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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72046

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2780-2015
Initiated
August 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
759 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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.

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.