Guidant ahs ongoing safety problems
March 7, 2006 13:40

The FDA warned Guidant again that it has failed to resolve problem found by the FDA. In December, the FDAhad harsh words for Guidant. Inspection of the caompany's cardiac unit in MN revealed problems.

The FDA found "significant violations" of good practices for manufacturing. There may be serious underlying problems. This may affect safety, quality control.

Guidant has recalled 100,000's of units. Doctors report at least 145 failrues of the seal on some units. There are projected to by 10's of thousands of more units with potential defects.

Documents from lawsuits shoudl that Guidant continued to sell units after knowing that the devices could malfunction.