Recall for Surgical Heart Valves, Edwards Lifesciences
2012.09.07
Product group Non-active implants - cardiac surgery
Reference 03504/12
Edwards Lifesciences recalls Carpentier-Edwards Porcine Valve Model 2625, SAV Porcine Valve Models 2650 and 6650, Carpentier-Edwards PERIMOUNT Models 2900, 6900P, and 6900PTFX, Carpentier-Edwards PERIMOUNT Magna Models 3000 and 3000TFX, Carpentier-Edwards PERIMOUNT Magna Ease Model 3300TFX, Carpentier-Edwards PERIMOUNT Magna Mitral Model 7000TFX, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Model 7300TFX, Edwards Sapien XT Transcatheter Heart Valve 9300TFX, Ascendra 2 Kit (for Transcatheter Valves), 9350AS223, 9350AS226, NovaFlex+ Kit (for Transcatheter Valves), 9355NF23, 9355NF26, NovaFlex Kit (for Transcatheter Valves), 9350NF23, 9350NF26. Edwards discovered that some of the valve jars containing the products with serial numbers listed above may contain one or more small particles. The particles are metallic and were introduced into the valve jars during the packaging process.
Recall for Surgical Heart Valves, Edwards Lifesciences , Download_VeroeffentlichtAm_EN