Recall for PERIMOUNT aortic, PERIMOUNT Plus, PERIMOUNT Magna Ease valves, Edwards Lifesciences
2009.08.05
Product group Non-active implants
Reference 04519/08
Edwards Lifesciences recalls PERIMOUNT aortic, PERIMOUNT Plus, PERIMOUNT Magna Ease valves. The storage conditions may have not been in alignment with the specified storage temperatures. If the valves were exposed to higher temperatures than estimated for a prolonged period of time, it may affect the long-term durability of the valve.
Edwards reports of the results of his additional investigation. This evaluation concluded that the valves have not been exposed to temperatures above the specified temperature limits as originally suspected.