Guidant letter about risks never sent

In June 2006, new unsealed court documents show that Guidant Corp. drafted a letter warning doctors of a dangerous electrical malfunction in some of its defibrillators designed to restore a normal heartbeat, however, the letter was never sent. Instead, a toned down letter was sent about a rare malfunction. Guidant officials worried about creating undue alarm.

Guidant executives told regulators that they believed there was a low risk of further problems from the flaw, despite two patient deaths at that point. Guidant ultimately ended up recalling 88,000 defibrillators including the two models at issue in the warning that was never sent to doctors. Guidant also has recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices. (CBS)