St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall
MedSun: Newsletter #82, March 2013

FDA MedWatch Safety Alert

In a small number of cases, the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. This recall is for all batches and model numbers of the AMPLATZER TorqVue FX Delivery System. The affected product was manufactured August 24, 2012 to September 24, 2012 and distributed October 1, 2012 – January 9, 2013.

Additional Information:

St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall. February 13, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm339593.htm


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