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FDA Warns of a Major Risk with St. Jude Heart Device

The FDA issued a Class I recall for St. Jude Medical, AMPLATZER TorqVue FX Delivery System on January 18, 2013. The wire insulation for the device may be faulty in some instances and could cause serious injury or death. The device is meant to repair holes in the heart atria. The devices that have been found to be faulty were manufactured between August 24 to September 24 of 2012. St. Judes Medical has had many problems and recalls of devices for faulty wires over the past several years.

To read the full article, click the link: http://www.nbcnews.com/id/50797322/ns/health/t/fda...

FDA recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/...