Over 700,000 HeartStart automatic external defibrillators (AEDs) were recalled by Phillips HealthCare in 2012. In November 2013, Phillips also warned that a defective HeartStart AED may fail to deliver a life-saving shock to a person in cardiac arrest. According to the Wall Street Journal, over 1,100 complaints and 580 adverse events have been reported to the FDA.
What You Can Do & How a HeartStart AED Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting HeartStart defibrillator / AED induced injury cases in all 50 states. If you or somebody you know was injured by a defective HeartStart defibrillator, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Covidien Recalls Electrodes – May Not Work With HeartStart AED
October 14, 2014 — Covidien is recalling Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes because they may not work with Philips HeartStart FR3 and HeartStart FRx defibrillators. Click here to read more.
What is the HeartStart AED?
Phillips HealthCare manufactures the Heart Start defibrillator, a battery-powered device that is used to deliver a life-saving electrical shock to patients in cardiac arrest. The device can restore normal heart rhythm in people with ventricular fibrillation, in which erratic electrical signals in the heart cause the lower chambers to flutter ineffectively instead of pumping blood.
What is the problem with HeartStart AED?
In December 2013, a Safety Communication issued by the U.S. Food and Drug Administration (FDA) announced that HeartStart defibrillators have a defective electrical component that may not deliver a life-saving shock in an emergency. The electrical component may also falsely indicate that the defibrillator is ready to use.
580 Adverse Events Linked to HeartStart AED
The Wall Street Journal and Jennifer Rodriguez, a spokeswoman for the FDA, report that the HeartStart AED has been linked to hundreds of adverse events:
“The FDA has received 1,100 complaints regarding the devices and 580 adverse event reports, Ms. Rodriguez said in an email. She could not immediately say whether any deaths or injuries had been reported.”
HeartStart AED Recall
Phillips initiated a Class II recall of the HeartStart AED in September 2012. Of the 700,000 products. According to Phillips, nearly half of the AEDs are located in the United States, and about 88% of customers have been notified of the recall.
HeartStart AED recall products include:
- HeartStart FRx AED: Used by Emergency Medical Service (EMS), fire departments, other first-responders.
- HeartStart HS1 Home: Used in the home.
- HeartStart HS1 OnSite: Used in public locations, such as malls, schools, airports, community centers, etc.
Do I have a HeartStart AED Lawsuit?
The Schmidt Firm, PLLC is currently accepting HeartStart AED induced injury cases in all 50 states. If you or somebody you know was injured by a defective HeartStart defibrillator, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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