Guidant Corp. has recalled its three millimeter-diameter Multi-Link Vision stent because some of the devices failed to stay in place and failed in quality tests. The recalled Guidant stent is a metal-mesh tube inserted into a coronary artery to prop it open after a blockage has been cleared.
The recall involves stents shipped in the United States and to Europe and Australia. Guidant received U.S. approval for the stents on July 16 from the Food and Drug Administration.
The recall of the Multi-Link stent comes just a few months after Guidant recalled its Ancure stent and pleaded guilty to 10 felonies and agreed to pay $92.4 million in civil and criminal penalties, to settle the federal charges that it withheld information about 2600 Ancure stent malfunctions. Ancure has been linked to at least 12 deaths and has failed 2400 times.
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