Recall Z-0217-2015— Edwards Lifesciences, LLC

Name: FDA recall Z-0217-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-08

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2014-10-08, terminated 2016-12-15. It names one FDA 510(k) clearance: K113411. 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..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Terminated: 2016-12-15
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULAEdwards Lifesciences, LLC·cleared 2012-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.