FDA and Guidant Failed to Timely Report Faulty Heart Devices
A recent article in the NY Times reported that the FDA new of the issues with Guidant heart devices for months before the warning release and recall in June. Guidant submitted it annual report to the the FDA in February, in which it disclosed that its Ventak Prizm 2 DR was short-circuiting at a rate of about once per month.
Guidant new of the heart device's flaw for years, but did not tell physicians about the problems until May of this year.
The FDA treats all annual reports as confidential and may not review the report until 90 days after receipt or longer.
Find a timeline of Guidant's deadly inaction here.