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St. Jude Device Recalled for Potential ‘Fracture’

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

By: Charles Lee

St. Jude Medical Inc. has recalled their device, the Amplatzer TorqVue FX Delivery System, and had urged customers and doctors to remove the device from their inventories. The end piece of the wire used for the TorqVue FX Delivery System contained a serious potentiality for fracture.

“If the device has already been used successfully, there is no case for concern or additional action,” St. Jude said in a statement. Besides a different design, physicians who are familiar with the device have been given the green light to use older versions.

Manufactured between August and September 2012 and distributed from October 2012 to January 2013, there have not been any fatal injuries or deaths. Used in about 120 medical procedures, the U.S. Food and Drug Administration has deemed the St. Jude recall a Class I- a description the agency uses to indicate a product’s ability to cause adverse health consequences.

“St. Jude Medical is taking a conservative approach in removing all remaining inventory.” The company plans on sales representatives to perform site visits to ensure recall activities are executed accordingly.

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