FDA-Device2013-11-20Class II
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.
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.
Sold states
Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Affected count
46
Manufactured in
5050 Nathan Ln N, Plymouth, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2014Don't want to check this manually?
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