Cardiac Science Defibrillator Recall: May Fail During Rescue Attempt

A number of automated external defibrillators (AEDs) manufactured by Cardiac Science Corporation have been recalled because they may fail to give life-saving shocks during emergency response situations. 

The Cardiac Science AED recall was classified by the FDA as a Class 1 medical device recall on March 2, suggesting that the agency believes the devices have a high likelihood of causing severe injury or death.

Cardiac Science first began warning customers in mid-January about potential problems with some models of the Powerheart, Cardiovive, CardioLife, GE Responder and Nihon-Kohden AEDs.

Although no injuries or deaths hav been reported in connection with the defective defibrillators, the FDA indicates that the devices have a component that may cause it to fail when they are needed to save someone’s life.

The recall affects the Cardiac Science Powerheart 9300, 9300P, 9390A and 9390E, as well as the CardioVive 92532, 92533 and CardioLife 9200G and 9231. GE Healthcare and Nihon Kohden also distributed defective Cardiac Science AEDs under their own labels, including the GE Responder and Responder Pro, and the Nihon-Kohden AED.

All of the AEDs were manufactured from July 1, 2011 through December 30, 2011. The FDA has provided a link to full list of serial numbers of devices affected by the recall.

Customers with questions can call the company at (888) 402-2484 or email them at aed210@cardiacscience.com.

Concerns over the safety of AEDs has been growing as the FDA has increasingly received reports of malfunctions and announced defibrillator recalls.

From January 1, 2005 to July 10, 2010 the FDA received more than 28,000 medical device reports on problems with defibrillators, including malfunctions that led to patient deaths. According to the FDA, there were 68 external defibrillator recalls during the that time period, with the number of recalls growing each year.

In 2005, there were nine recalls, but in 2009 there were 17. During the same time period, the FDA received more than 28,000 MDRs of defibrillator problems. That number, too, increased over the years from 4,210 reports in 2005 to 7,807 reports last year.

In November 2010, the FDA sent a letter to medical device manufacturers warning them that if they could face stricter regulation of external defibrillators if they did not take action to address the recurring problems.