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U.S. Department of Health and Human Services

Class 2 Device Recall Therapy Ablation Catheter

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  Class 2 Device Recall Therapy Ablation Catheter see related information
Date Initiated by Firm February 10, 2011
Date Posted September 16, 2011
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-3256-2011
Recall Event ID 59683
PMA Number P040014 
Product Classification Cardiac Ablation Percutaneous Catheter - Product Code LPB
Product 7 F Therapy Ablation Catheter,
4 mm Tip Thermistor,
Model (Reorder #) 83725,
Description: 1304-7-25-L-TH.
St Jude Medical Company

A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.
Code Information Model: 83725. Lots: 3200476, K21432, K24495, K25197, K28752, K30681, and K30881.
Recalling Firm/
Manufacturer		 St Jude Medical
One St Jude Medical Dr
Saint Paul MN 55117
Manufacturer Reason
for Recall		 The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.
FDA Determined
Cause 2		 Process control
Action St. Jude Medical sent an "important Medical Device Safety Information" letter dated February 22, 2011 to all affected customers. The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form. For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.
Quantity in Commerce 179 units total
Distribution Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
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 = LPB and Original Applicant = IRVINE BIOMEDICAL, INC.
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