GUIDANT

Pacemaker

The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients that Guidant Corporation is voluntarily recalling certain pacemakers. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.
( Guidant Pacemaker )

Implantable Defibrillators

As the Food and Drug Administration (FDA) continues to evaluate the safety and performance of certain implantable defibrillators manufactured by Guidant Corporation, the Agency has now classified the recalled devices. This additional information on the relative health risks of the devices will help patients and doctors take appropriate action, if necessary.
( Guidant Defribillators )

Ancure Endograft System

EndoVascular Technologies, a subsidiary of Guidant Corporation, recently agreed to pay $92.4 million to settle criminal and civil charges, including 10 counts of fraudulently shipping a misbranded product and making a false statement to the Food and Drug Administration. The $92.4 million is purportedly the largest penalty ever given for failing to report a faulty medical product to the FDA.

Guidant has plead guilty to covering up malfunctions of its Ancure Endograft System, used to treat abdominal aortic aneurysms, which may have led to 12 deaths and 57 emergency surgeries nationwide.
( Guidant Ancure Endograft System )

• Guidant Corporation Web Site
  
• Guidant adds to heart-device alerts on 28,000 older pacemakers
  
• Guidant to discontinue product for treating abdominal aortic aneurysms
• Guidant faces possible class-action shareholders lawsuit
• Class action suit coming after Guidant fined $92M in coverup
• Heart device maker pleads guilty to cover-up