Z-1542-2013Class II

QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The...

Name: Z-1542-2013 QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The...
Creator: Edwards Lifesciences, LLC
Published: 2013-05-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-05-14 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of 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... on 2013-05-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1542-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-14
Posted: 2013-06-13
Terminated: 2014-10-14
Recalling firm: Edwards Lifesciences LLC
Product: 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.
Product code: DWS Instruments, Surgical, Cardiovascular
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 22,616
Distribution: Worldwide distribution: US Nationwide and country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1542-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1542-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12

Product code DWS

K981995Class IIQuickdraw Venous CannulaHeartport, Inc. / cleared 1999-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)