Recalled St. Jude ICD Linked to Two Deaths
After two people died, the FDA demanded that St. Jude Medical recall 400,000 of its St. Jude ICD devices worldwide. St. Jude made these devices before May 2015, and they are at risk of premature battery depletion. Lithium cluster formations make the affected devices susceptible to short-circuiting. This can cause total battery failure in as little as 24 hours.
About the St. Jude ICD
An implantable cardiac defibrillator (ICD) is a small cardiac device placed in the chest or abdomen to help maintain a normal heart rhythm. Colloquially, these are called pacemakers. The ICD provides pacing for slow heart rhythms, and an electrical shock to stop extremely fast heart rhythms. ICDs are powdered by lithium-based batteries. Following implantation, an ICD’s battery power slowly begins to deplete. When the charge level is low, it sends a notification to the patient informing them it is time to have the battery replaced.
However, those ICDs manufactured by St. Jude Medical can lose charge very quickly often without an adequate warning. This may leave patients with mere hours to undergo a replacement surgery before the device stops working entirely. Consequently, patients may be left without the needed pacing or shocks provided by the ICD to keep their hearts functioning correctly. This had the potential to lead to severe, and even fatal, complications.
Recalled St. Jude ICD Devices
In October 2016, the FDA initiated a formal recall of the St. Jude ICD. This was a Class 1 Recall, which is the highest and most serious level. This level involves products that can cause severe health problems and even death.
The recall involved the following devices, which St. Jude manufactured between January 2010 and May 2015 and distributed between February 2010 and October 2016. The U.S. recall affects upwards of 250,000 devices:
- Fortify VR: Model No(s). CD1231-40, CD1231-40Q
- Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
- Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
- Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
- Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
- Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
- Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
- Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
- Unify: Model No(s). CD3231-40, CD3231-40Q
- Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
- Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
- Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
- Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C
We Want to Help Recalled St. Jude ICD Victims
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury as a result of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other women and their families from needless distress.
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. Why did St. Jude not tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.