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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description 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.
Recall Number Z-0187-2014
Classification Class II
Code Info Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
Product Distributed Qty 46
Reason For Recall 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.

Event Detail

Event Id 66574
Product Type Devices
Status Ongoing
Recalling Firm St. Jude Medical
City Plymouth
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of KY, OH, TX, MA, and NC.