February 3, 2014 — The U.S. Food and Drug Administration (FDA) issued a Class I Recall of Edwards Lifesciences LLC’s Embol-X Glide Protection System due to deformed cannula trip. Applying force to the tip during insertion or removal may lead to separation and embolization. Use of the recalled product may cause serious adverse health consequences, including death.
This recall includes model numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Edwards Lifesciences recalled all unexpired lot numbers of the Embol-X Glide Protection System Cannulae.
The Embol-X access device system is designed to capture material such as blood clots or tissue fragments during short-term cardiopulmonary bypass surgery.
For more information: www.fda.gov, www.edwards.com