About 12,200 automated external defibrillators (AEDs) manufactured by Cardiac Science Corporation are being recalled because they may fail to deliver life-saving shocks when needed.
The defibrillator recall was announced on February 3 by FDA after Cardiac Science determined that the AEDs were defectively manufactured. The recalled units may not function correctly during a resuscitation attempt, which could lead to serious injury or death, the company said. The recall is a Class 1 recall, the most serious medical device recall category.
There have been no failure incidents reported in connection to the defective AEDs. The defect was found by internal quality control at Cardiac Science Corporation.
The AED recall affects Cardiac Science’s Powerheart 9300A, 9300E, 9390A and 9390E, as well as the CardioVive 92532, the CardioLife 9200G and 9231. The recall is a separate issue from a medical device correction alert issued by the company on November 13 dealing with some of its defibrillators.
The affected AEDs were manufactured between October 19, 2009 and January 15, 2010. Any customers who purchased an AEDs during that time can check Cardiac Science’s website to determine whether their unit is affected by the recall. The company is also informing customers by letter.
Replacement defibrillators will be available after February 15 and will be replaced at no charge.
The company recommends that any recalled defibrillators be immediately taken out of service.