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St. Jude Heart Delivery System Part of Class I FDA Recall

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Not long after St. Jude Medical Inc. of St. Paul, Minnesota, received a warning missive from the Food and Drug Administration, January 17, 2013, citing problems with its manufacturing processes in a California plant, the Company has voluntarily recalled another of its products, the Amplatzer TorqVue delivery system.

The Amplatzer TorqVue FX Delivery System is designed to assist the attachment, loading, delivery and deployment of the Amplatzer Occluder devices used to close openings between the two upper chambers of the heart. According to an article on Bloomberg.com, February 12, the core wire in the delivery system "may fracture, causing serious damage and perhaps death," to patients in whom the system is implanted.

In 2010, St. Jude Medical halted the sale of its Riata lead used to connect the heart of a patients to a defibrillator, indicating that the leads could perforate the wire’s coating and possibly cause shocks to the patient. St. Jude also recalled the QuickSite and QuickFlex left-ventricle leads noting that those lead wires could also perforate their coating, exposing the patients to shocks.

St. Jude Medical’s spokesperson Amy Jo Meyer, indicated that physicians can still use an "older version of the [St. Jude] delivery system" for the same purpose, i.e., closing a hole between the chambers of the heart to help prevent blood clots from moving to the brain. (Bloomberg.com, 2/12/13) St. Jude also indicated the Company had informed physicians of the voluntary recall last month upon learning that the device could cause problems for some heart patients, and that it was not aware of any serious injuries having occurred.