AUDIENCE: Risk Manager, Cardiology
ISSUE: FDA notified healthcare professionals that Edwards Lifesciences LLC issued a Class I Recall of the EMBOL-X Glide Protection System. The tip of the catheter is being recalled due to a deformed cannula tip. When force is applied to the tip during insertion or removal, it may lead to a separation and embolize. Use of this 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 is recalling all lot numbers of the EMBOL-X Glide Protection System Cannulae that have not expired.
BACKGROUND: The EMBOL-X access device system can help capture material such as blood clots or tissue fragments during short-term (equal to or less than 6 hours) cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system.
RECOMMENDATION: On Sept. 16, 2013 the firm sent their customers an Urgent Field Safety Notice, with instructions for quarantine and return of the affected products. Call Edwards Customer Service at 800-424-3278 from 6:00 AM – 4:30 PM Pacific Standard Time or contact your Edwards sales representative concerning this recall.
[11/04/2013 - Recall Notice - FDA]