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U.S. Department of Health and Human Services

Class 2 Device Recall Safire Duo Ablation Catheter MediGuide Enabled

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  Class 2 Device Recall Safire Duo Ablation Catheter MediGuide Enabled see related information
Date Initiated by Firm October 11, 2013
Date Posted November 08, 2013
Recall Status1 Terminated 3 on June 09, 2014
Recall Number Z-0187-2014
Recall Event ID 66574
PMA Number P110016S003 
Product Classification catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
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.
Code Information Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
Recalling Firm/
St. Jude Medical
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Rachel Ellingson
Manufacturer 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.
FDA Determined
Cause 2
Process change control
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.
Quantity in Commerce 46
Distribution Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OAD and Original Applicant = Abbott Medical