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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65173

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

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Event summary

Timeline bucket
May 14, 2013
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

QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed, peel-type pouch.

Z-1542-2013
Recall number
Z-1542-2013
Initiated
May 14, 2013
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
22,616

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

Code information

Model QD22: Lot No. 59049758, 59054488, 59067502, 59074170, 59081626, 59083736, 59091652, 59094887, 59114755, 59117451, 59134508, 59149651, 59154310, 59178579, 59201243, 59212118, 59222657, 59233636, 59233637, 59246684, 59246701, 59255899, 59255900, 59269439, 59284780, 59287725, 59296462, 59299605, 59315339, 59320575, 59334652, 59356129, 59360072, 59365198, 59365199, 59374009, 59384309, 59390552, 59394166, 59394167, 59421250, 59448841 Model QD25: Lot No. 59046082,59046847,59052393,59052395,59056270,59059029,59060798,59062681,59069772,59073141,59077234,59079573,59085168,59085169,59097289,59101637,59106005,59110720,59122491,59126281,59131923,59140133,59142266,59143453,59145027,59158524,59158579,59163164,59184252,59191107,59201246,59207044,59209886,59214360,59214361,59216991,59222658,59222659,59233651,59246685,59246703,59255901,59268625,59284781,59287728,59296463,59299610,59313057,59320582,59320583,59334656,59344191,59346468,59352608,59356135,59360084,59374014,59374015,59414791,59425355,59437699,59437700,59448853

Distribution pattern

Worldwide distribution: US Nationwide and country of Canada.