The Seattle Times

July 20, 2009

Cardiac Science will replace about 24,000 automated external defibrillators (AEDs) for U.S. medical facilities and emergency services under a revised recall plan the Bothell company has negotiated with the Food and Drug Administration.

The move expands on a limited recall announced by Cardiac Science in November.

CEO Dave Marver said the replacement program is expected to cost between $10 million and $15 million, on top of the previously announced charge of $18.5 million last fall. The company will finance the recall with a combination of cash and a larger credit line.

"Without question, the resolution of this matter is very good news for the company," Marver said in a blog post on the company's website. "I'm pleased to have resolved this matter with the FDA in such a way that we are now aligned. Both the company and the FDA are communicating similar guidance to users, eliminating any angst or confusion among our customer base."

But Marver acknowledged the company's FDA issues are not over. The agency issued a warning letter to Cardiac in February over quality control issues, mostly relating to documentation.

"The effort is receiving our full attention and we've already resolved most of the issues," Marver wrote, citing monthly progress reports provided to regulators. "We will continue to give these matters top priority until they are fully resolved and the warning letter is closed."