Home / Recalls / Medical Devices
St. Jude Medical recalls Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating e
Recalled November 20, 2013 · FDA recall Z-0187-2014 · St. Jude Medical
Hazard
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended. · FDA Class II
Units
46
Sold at
Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Description
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
Product
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Manufacturer(s)
St. Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →