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Class I FDA Recall of Edwards Lifesciences EMBOL-X Glide Protection System

Nov 5, 2013

Edwards Lifesciences has recalled all lot numbers of the EMBOL-X Glide Protection System Cannulae that have not expired.

This is a Class I recall, the most serious recall category, which the FDA reserves for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

The EMBOL-X Glide Protection System, used in cardiopulmonary bypass surgery, was manufactured from Sept. 21, 2010 through July 12, 2013 and distributed from Sept. 21, 2010 through Aug. 22, 2013. To locate the part number of the lots involved in the recall, customers should refer to the firm’s Urgent Field Safety Notice, posted on the U.S. Food and Drug Administration (FDA) website.

According to the FDA, the EMBOL-X access device system is used during short-term cardiopulmonary bypass surgery to help capture material such as blood clots or tissue fragments when surgeons may need to introduce and remove devices into the vascular system. The product is being recalled because the tip of the catheter is deformed. Use of this device may cause serious adverse health consequences, including death, the FDA warns.

Customers affected by this recall may contact Edwards Customer Service at 800-424-3278 from 6:00 a.m. to 4:30 p.m. Pacific Standard Time or contact their Edwards sales representative. Anyone with recalled lots on hand should immediately quarantine the affected material and return the products to Edwards. The FDA further instructs customers to notify others to whom the potentially affected devices have been transferred.

The FDA encourages healthcare professionals and consumers to report adverse reactions or quality problems with these products through the MedWatch Adverse Event Reporting Program.

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