Terminated

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.

FDA Recall Z-0217-2015 · Posted 2014-11-14

Recalling FirmEdwards Lifesciences, LLC

Recall StatusTerminated

Product CodeDWF

Date Initiated2014-10-08

Date Terminated2016-12-15

Product Quantity157,305

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113411EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULAEdwards Lifesciences, LLC · 2012-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.