Z-0217-2015Class II

Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model...

Name: Z-0217-2015 Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model...
Creator: Edwards Lifesciences, LLC
Published: 2014-10-08
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2014-10-08 / Terminated / root cause: design

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent... on 2014-10-08. FDA classified it as Class II and gives the reason as "Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0217-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Posted: 2014-11-14
Terminated: 2016-12-15
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.
Root cause tag: design
FDA root cause: Device Design
Action: Edward Lifesciences sent an Urgent Medical Device Safety Notice date October 8, 2014, via Fed-Ex to all affected customers. On 3/4/15, letters were sent to surgeons. As part of the customer instructions in the safely notice, customers were requested to forward copies of the safely alert to any organization where the potentially affected devices have been transferred. No product is being returned. The distribution of the device has not been stopped as a result of this field correction. No additional production lots will be released for distribution until the IFU has been revised. Customers with questions were instructed to call (800) 424-3278. For questions regarding this recall call 801-553-7531.
Quantity in commerce: 157,305
Distribution: Worldwide Distribution - USA including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia. US Territory: Puerto Rico and Internationally to Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Singapore, South Korea, Sri Lanka, Taiwan, and Venezuela.
Product codes and lots: Lots: 59134589;59346136;59499481;59609044;59717943;59138591;59192007;59149674;59350916;59514123;59620244;59723313;59138592;59199148;59202405;59370449;59528372;59625386;59723318;59148881;59207364;59222648;59409903;59528392;59634884;59735991;59149673;59211452;59245610;59414824;59541717;59651860;59747795;59149675;59211456;59245648;59453572;59555076;59662625;59758989;59151406;59216325;59266772;59456447;59563964;59680248;59769429;59161706;59218844;59283731;59458072;59568501;59691477;59774986;59163769;59229509;59309184;59463365;59577224;59695811;59791798;59179981;59229512;59319451;59490087;59604744;59706987;59813426;59182987;59232182;59342295;59491855;59604746;59717942;59839270;59192002;59235535;59245625;59328438;59409901;59509316;59615872;59680180;59758991;59245650;59328440;59413359;59518784;59615876;59680270;59759002;59245652;59329235;59414819;59523751;59620242;59684868;59763554;59258285;59346138;59431972;59531242;59620243;59702379;59774995;59271794;59346146;59453598;59536690;59620327;59706982;59780342;59271795;59350911;59456450;59541842;59630423;59706985;59786179;59283729;59350921;59458056;59555081;59634892;59712080;59796688;59287254;59354987;59458061;59563850;59634893;59712081;59796692;59290438;59354988;59463367;59568469;59640081;59723317;59801791;59295439;59365157;59473421;59572996;59640085;59723320;59813418;59295506;59365159;59473422;59577180;59640108;59729757;59824882;59299876;59378069;59484139;59581494;59651780;59729759;59824891;59304307;59383861;59490088;59581564;59651850;59729761;59836965;59304308;59390115;59490089;59583327;59662626;59735981;59839272;59304310;59390121;59491856;59589933;59662638;59735983;59844549;59312984;59391051;59491858;59589951;59675187;59735987;59319447;59404539;59499480;59604747;59680142;59747805;59321329;59409878;59504238;59609041;59680148;59751061;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0217-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0217-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-14

Product code DWF

K113411Class IIEdward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic Perfusion CannulaEdwards Lifesciences, LLC / cleared 2012-06-11

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)