Edwards Lifesciences, LLC 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 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
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
Products Sold
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;
Edwards Lifesciences, LLC is recalling Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pou due to 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. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, MO, MT, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026