Cardiac Science recalls 12,000 defibrillators

Cardiac Science of Bothell said it is recalling more than 12,000 automated external defibrillators (AEDs) after discovering they "may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death."

AEDs are used to re-establish a normal heartbeat in a person suffering from ventricular fibrillation, which is irregular and uncoordinated contractions of the heart's lower chambers.

The worldwide recall involves devices manufactured or serviced between Oct. 19 and Jan. 15, the company said.

Cardiac Science reported several other AED quality-control problems in the past year. The most significant one prompted the company to halt $3 million in AED shipments in late June "to evaluate a potential component issue"; it resumed shipments by early August.

In November the company said about 300,000 of its AEDs were in use.

Cardiac Science said it detected the latest problem itself through internal quality-control checks, and has not received any complaints or reports of malfunctions in the field.

The company said the AEDs "were manufactured in a way that makes them potentially susceptible to failure under certain conditions."

Cardiac Science said it will book a charge of $2 million to $3 million in the fourth quarter for the recall's estimated cost.

This story was originally published Feb. 3, 2010, and corrected the next day. It originally said AEDs are used to re-establish a normal heartbeat in a person suffering from atrial fibrillation, irregular and uncoordinated contractions of the heart's upper chambers. But it actually is used on people suffering from ventricular fibrillation, involving irregular contractions of the heart's lower chambers.