FDA Update: INGENIO Family of Pacemakers, CRT-Ps Recalled
The U.S. Food and Drug Administration (FDA) has issued a Class I recall of Boston Scientific's INGENIO family of pacemakers and CRT-Ps, including the ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL models that were manufactured between September 2011 and December 2018, due to a risk of incorrect transition to safety mode. The devices are used in patients with low heart rates or with moderate to severe heart failure. There have been 65 reported incidents, including three injuries that required temporary external pacing. No deaths have been reported.
Keywords: United States Food and Drug Administration, Heart Rate, Pacemaker, Artificial, Heart Failure, Bradycardia, Risk Management, ACC Advocacy
< Back to Listings