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St. Jude ICD Product Recall
In June 2005, St. Jude Medical issued a warning to doctors and medical professionals that some of its Implantable Cardioverter Defibrillators (ICD) may need software upgrades. Shortly after, the FDA announced a recall on the following product families after the discovery of 52 reported events in the FDA database related to St. Jude's Epic and Atlas products.
Of these 52 reported instances by consumers using the pacemaker-like devices, 10 are related to the "reset" mode which can result in the defibrillator function shutting off without warning. The reset mode can be triggered when simply exposed to intense electrical or magnetic activity. The FDA states that they are recalling the products for software upgrades due to the Skipped-Charge Shock and a Sensor Noise Anomaly.
Recalled St. Jude ICDs:
EPIC (Models V-233, V337, V-338)
EPIC PLUS DR/VR/HF (Models V-236, V-239, V-239T, V-196, V-196T, V-350)
ATLAS DR (Model V-242)
ATLAS PLUS DR/VR/HF(Models V-242, V-193, V-193C, V-340, V-341, V-343)
These pacemaker-like devices are used by patients with life-threatening heartbeat rhythm problems and are designed to provide cardiac resynchronization therapy to keep the heartbeat in steady rhythm. Many of these implanted devices were only recently approved by the FDA but have already been distributed to 30,000 U.S. patients and 11,684 international patients.
Patients who are using one of these recalled St. Jude ICDs should seek advice from their doctor to undergo the software upgrade process.
Register your St. Jude ICD ComplaintIf you or a loved one has suffered from a St. Jude ICD, you may qualify for damages or remedies that may be awarded in a possible St. Jude ICD lawsuit. Please click the link below to submit your complaint and we will have a lawyer review your St. Jude ICD complaint.
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Last updated on Aug-30-05
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My dad just had a St. Jude ICD model CD1357-40Q replaced after 13 months, malfunction of capacitor/battery. have you had any suits on this. They replaced with same model, suppose to be good for about 10 years.
My husband had to defibrillator pacemaker put in so he was having issues with finished with blue flashes that would bring them down to ground we went back to Saint Jude and they said everything's fine with in a couple months if he passed away I found out to another lawyer in New York that they had a lawsuit against Saint Jude and they said they couldn't do anything because the product was not me called I found out the product was recalled just do you couple days ago need to find out if the pacemaker defibrillator reader we're default All his medical records even the card for the pacemaker
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