Safety Notice for aortic root bioprosthesis TLPB-A Supra 21, 23, 25 mm, Freelife
2011.06.15
Product group Non-active implants
Reference 01222/11
Freelife reports of the quarantine of concerned Lots of aortic root bioprosthesis TLPB-A Supra 21, 23, 25 mm Labcor Laboratórios Bioprothetic Heart Valve. In France there have been two cases of late endocarditis (7 and 17 month after surgery) may be eventually caused by contaminated Labcor Procine Bioprostheses.
Please note: Taking into account the results of the recent investigations of the french Competent Authority (AFSSAPS), suspicion of contaminated valves has not been confirmed.