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Class I Recall Issued For St. Jude Riata Leads

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A Class I recall, the U.S. Food & Drug Administration’s (FDA) most serious designation, has been issued for St. Jude Medical Inc.’s Riata leads. The recall involves the performance of Riata® and Riata® ST Silicone Defibrillation Leads. The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected

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devices malfunction. Last year, St. Jude sent a letter to physicians explaining that the devices’ cables with newer coating experienced less problems and have almost replaced older versions (the phase-out is expected to be completed by year end); At the time the letter was sent, an FDA spokeswoman said that the issue did not warrant a recall. The FDA’s upgraded classification that was announced yesterday updates prior recommendations made in the November 28, 2011 Physician Advisory Letter. St. Jude Medical Inc.’s Riata stopped selling the devices last year, noted Bloomberg Businessweek. The problem exists with “Riata and Riata ST” leads, or cables, that connect defibrillators to the heart. The FDA noted that should the lead’s electrical integrity be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). All leads with an externalized conductor, with or without an associated electrical abnormality, are to be reported to the St. Jude Medical’s Technical Services Department at 1.800.722.3774. Leads removed from the patient should be returned to the company, at company expense, for failure analysis. Any adverse reactions experienced with the use of the device, and/or quality problems also should be reported to the FDA’s MedWatch Program by phone at 1.800.FDA.1088; by Fax at 1.800.FDA.0178; by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or via the MedWatch website at www.fda.gov/medwatch. St. Jude recommends that physicians continue monitoring patients with the “Riata” brand cables while they continued its testing of possible lead failures in patients in which there existed a concern; 227,000 of the faulty cables have been sold worldwide.

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