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.
FDA Recall Z-0187-2014 · Posted 2013-11-08
Recalling FirmSt. Jude Medical
Recall StatusTerminated
Product CodeOAD
Date Initiated2013-10-11
Date Terminated2014-06-09
Product Quantity46
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.
Firm Action
Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.
Root Cause
Process change control
Distribution Pattern
Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.