Guidant Initiates Voluntary Recall of 3.0mm-Diameter MULTI-LINK VISION Coronary Stent SystemOct 8, 2003 | BUSINESS WIRE Guidant CorporatioN, a world leader in the treatment of cardiac and vascular disease, today announced that it has initiated a voluntary recall of certain manufacturing lots of the 3.0 mm diameter MULTI-LINK VISION(TM) Coronary Stent System.
The action will affect customers in the United States, Europe and Australia. Working with the Food and Drug Administration and other regulatory bodies, Guidant has taken action to address this matter and is currently shipping 3.0 mm diameter MULTI-LINK VISION stents to customers worldwide.
Patients who have received the MULTI-LINK VISION Stent are not affected by this action. The safety and effectiveness of the implanted product is supported by positive long-term clinical data. This action is due to a limited amount of product that did not meet Guidant's manufacturing specification for stent retention. Affected physicians and regulatory bodies have been notified.