Company Hid Serious Problems with Aorta Graft Product
Is investigating possible lawsuits against EndoVascular Technologies, Inc., a wholly-owned subsidiary of medical device manufacturer Guidant Corporation , on behalf of persons who were implanted with the Guidant EndoVascular's Ancure Endograft System, which is used to repair abdominal aorta aneurysms. EndoVascular/Guidant has now admitted that Guidant lied to the government and concealed serious problems with the device, leading to at least a dozen deaths. Guidant has also pled guilty to 10 felonies in a prosecution by the U.S. government.
Guidant Lawyer | Guidant Recall Lawyer
The federal Food and Drug Administration approved the Guidant Ancure system on September 28, 1999. The scope of the problems began to surface in the fall of 2000, when seven anonymous employees sent a letter to the FDA providing details about the failures and problems that were occurring. EndoVascular/Guidant recalled the Ancure system on March 16, 2001, and reintroduced it in August of that year. While the company previously submitted 172 reports of problems, it has now admitted that the real number was much higher: 2,628 additional reports of problems, out of a total of 7,632 Guidant devices that were sold.
Guidant Lawyer | Guidant Recall Lawyer
The problems with the Guidant device centered on the system used to insert it. The equipment could become lodged, potentially requiring emergency surgery to remove it. In some cases, it was broken into pieces before being removed--a technique devised by sales representatives.
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On September 22, 2005, Guidant Corp. announced warnings for two additional pacemakers-the Insignia and the Nexus. These devices can fail, resulting in sudden and intermittent or permanent loss of pacing.
The FDA announced on July 1, 2005 that 20,600 Guidant defibrillators would be given the highest recall priority. According to the FDA, these devices have a "reasonable probability" of malfunctioning and could cause serious injuries or even death. The devices classified as highest priority include:
Guidant further announced on July 18, 2005 that some 28,000 pacemakers were potentially dangerous and may need to be replaced. The company indicated it was aware of 69 failures among these pacemakers, all manufactured between 1997 and 2000.
The problems involve a degraded sealing component that may allow excessive moisture into the devices. The company has recommended that doctors consider replacing the devices.
The FDA is considering whether to classify this warning as a recall of the affected pacemaker devices.
Affected models include:
Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR.
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