Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall
MedSun: Newsletter #89, November 2013
FDA MedWatch Safety Alert
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. On Sept. 16, 2013 the firm sent their customers an Urgent Field Safety Notice, with instructions for quarantine and return of the affected products.
Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall. FDA MedWatch Safety Alert. November 4, 2013.