Guidant stent recall
This article was originally published in The Gray Sheet
Executive Summary
Voluntary recall initiated of certain lots in the U.S., Europe and Australia following reports of 3.0 mm Multi-Link Vision becoming dislodged from delivery balloon in packaging. Implanted patients are unaffected. Guidant is working with U.S. and European regulatory bodies to replace the coronary stent systems, made in California and Ireland. According to the firm, the action will not affect its drug-eluting stent program, for which Vision is the platform...