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FDA Knew Of Pacemaker Problems Before Recall

September 13, 2005
FEMA's not the only federal agency that moves slowly. The Food and Drug Administration was reportedly warned about problems with Guidant's heart devices months before the agency issued a safety alert.

• Medtronic Withdaws Defibrillator Wires • Guidant Settles Defibrillator Charges For $16.7 Million • Court Orders Guidant To Release Documents • FDA Warns Guidant About Its Heart Devices • Spitzer Sues Guidant for Hiding Defibrillator Defect • FDA Report Addresses Heart Device Malfunctions • Potentially Harmful Medical Devices Should Be Recalled, Public Citizen Tells FDA • FDA Knew Of Pacemaker Problems Before Recall • Guidant To Resume Defibrillator Sales • Guidant Recalls Pacemakers • Guidant Pacemakers May Be Recalled • FDA Upgrades Guidant Recalls • Guidant Finds More Defibrillator Problems • FDA Recalls Guidant Implantable Defibrillators • Company Withheld News of Flaw in Defibrillator • Medicare To Cover More Defibrillators

The New York Times reports the agency received data in February showing Guidant’s defibrillator, the Ventak Prizm 2 DR, was short-circuiting. However, the FDA recall was not announced until the beginning of July.

The FDA has been under fire for months from critics who charge the agency has glossed over warnings and concerns about health care products, in effect giving pharmaceutical companies gentle treatment. Some critics charge FDA officials have ignored warnings from its own technical staff.

The defibrillator devices are thought to have been implanted in around 46,000 patients.

In May, Guidant disclosed that it knew about a design defect in its defibrillator for three years but had not told doctors about the problem. The company said it changed the design in 2002 to remedy the problem. At the time, the company contended it had followed FDA guidelines in reporting problems to the agency.

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