FDA Device recall Z-0217-2015
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch
- FDA Device
- Class II
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class II recall of Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch by Edwards Lifesciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0217-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-08 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
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.
Reason
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.
Identifiers
| code_info | Lots: 59134589;59346136;59499481;59609044;59717943;59138591;59192007;59149674;59350916;59514123;59620244;59723313;59138…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;5970 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0217-2015%22
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