Recall of SynCardia temporary Total Artificial Heart (TAH-t) with bi-leaflet mechanical valves, SynCardia Systems, Inc.
2013.09.03
Product group Active implantable medical devices - artificial hearts
Reference 04653/13
Recall of implantable temporary Total Artificial Heart (TAH-t) protheses, equipped with bi-leaflet mechanical valves, of SynCardia Systems, Inc. Tucson, Arizona, USA due to possible risk of excessive wear of valves.