Edwards Lifesciences is recalling its EMBOL-X Glide Protection System due to a defect in the catheter tip that if used may cause serious or deadly complications.
The EMBOL-X Glide is a device used to help capture material such as blood clots or tissue fragments during short-term cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system.
This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Edwards Lifesciences is recalling all lots that are not expired, including lot numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X Glide Protection System was manufactured From Sept. 21, 2010 through July 12, 2013 and distributed from Sept. 21, 2010 through Aug. 22, 2013.
Any side effects with this device should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.