More info on Prestige Recall

[sahuaro]

I just spoke with Bert Kelly at Medtronic--the name and number listed on the FDA recall page as the contact person. The recall has to do with the sizing guide. He said that they were having different results depending on the size of the patient with the sizing guide so it has been redesigned to be consistent independent of patient size. He indicated that the recall was made in September and all the sizing guides involved were returned by October, so there are no recalled parts in the field. He also indicated that over 1000 Prestige ST's had been implanted since the summer (i.e., FDA approval). Whew!