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U.S. Department of Health and Human Services

Class 2 Device Recall US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter, MediGuide Enab

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  Class 2 Device Recall US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter, MediGuide Enab see related information
Date Initiated by Firm October 11, 2013
Date Posted November 06, 2013
Recall Status1 Terminated 3 on March 10, 2016
Recall Number Z-0174-2014
Recall Event ID 66597
PMA Number P110016S003 
Product Classification catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Product US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO.

The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
Code Information Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.
Recalling Firm/
Manufacturer		 St. Jude Medical
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Rachel Ellingson
651-756-2295
Manufacturer Reason
for Recall		 St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
FDA Determined
Cause 2		 Error in labeling
Action The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU. If you have any questions, contact Vice President, Quality, at 651-756-5402.
Quantity in Commerce 59
Distribution US distribution: KS, MA, UT,TX, KY, OH.
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
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