Edition:
United Kingdom

FDA Identifies Edwards Lifesciences' Sapien Heart Valve Recall As Class I


Thursday, 22 Aug 2019 

Aug 22 (Reuters) - U.S. FDA::EDWARDS LIFESCIENCES RECALLS SAPIEN 3 ULTRA DELIVERY SYSTEM DUE TO BURST BALLOONS DURING SURGERY, WHICH MAY RESULT IN VASCULAR INJURY, BLEEDING, OR SURGICAL INTERVENTION.FDA - 17 INJURIES & 1 DEATH REPORTED AT TIME WHEN EDWARDS INITIATED FIELD CORRECTIVE ACTION IN JULY ON SAPIEN 3 ULTRA DELIVERY SYSTEM .FDA SAYS HAS IDENTIFIED EDWARDS LIFESCIENCES LLC'S SAPIEN 3 RECALL AS A CLASS I RECALL.FDA - EDWARDS LIFESCIENCES RECALLED 1,585 SAPIEN 3 DEVICES IN U.S..