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FDA discusses issue with heart pump device, HeartMate II

Posted on April 5th, 2012 No Comments

The Food and Drug Administration has recently discussed issues with the heart pump device, the HeartMate II and has published a detailed explanation of the malfunctions on their website.

According to the website, the HeartMate II, manufactured by Thoratec Corp, discusses the bloodflow problems that are associated with the device. The FDA originally posted the issues on March 23 and then reposted them on Wednesday.

This caused the company’s stock to spiral downward by 13 percent. Thoratec told doctors about the issues last month and have already updated the label to include a cautionary statement and instructions on how to properly implant the device so that the blood will flow correctly. No devices have been recalled yet and consumers should continue to use them at this time.

Poorly manufactured devices can cause serious injury or illness. On example is the DePuy Hip Replacement System that caused serious injury to patients when the metal-on-metal device caused particles to go into the bloodstream. If this happened to you or loved one, you need experienced representation on your side at this time. Contact the DePuy hip recall lawyers of Williams Hart today by calling 800-761-3187.

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