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QuickDraw Venous Cannula with Insertion Kit. ThruPort… recallZ-1542-2013 · Edwards Lifesciences, LLC · initiated May 14, 2013

Class II Terminated All recalls posted in June 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process design

What the company is doing

The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL - ACTION REQUIRED" notice dated May 14, 2013 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review our entire inventory for any QuickDraw Venus Cannula that has not expired; quarantine affected product from your inventory; discontinue use and return unused devices; complete and return the acknowledgment form via fax to Edwards Customer Service on 800-422-9329 within three days of receipt of this Field Safey Notice; contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number and replacement product; return product to Edwards Lifesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020 Attention: RECALL, RGA#xxxxxx. If you have any questions that have not been answered by this notice, please call Edwards Customer Service at 800-424-3278 from the hours of 6:00AM - 4:30PM PST.

Recall details

Recall number
Z-1542-2013
Recall class
Class II
Status
Terminated
Initiated by the company
May 14, 2013
Posted by the FDA
Jun 13, 2013
Recalling firm
Edwards Lifesciences, LLC
Quantity
22,616
Product code
DWS
FDA submissions
K981995
Distribution
Worldwide distribution: US Nationwide and country of Canada.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

1 device cleared under K981995 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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