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U.S. Department of Health and Human Services

Class 2 Device Recall 1500T9 Cardiac Ablation Generator

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 Class 2 Recall
1500T9 Cardiac Ablation Generator
see related information
Date Posted February 14, 2012
Recall Status1 Open
Recall Number Z-1032-2012
Recall Event ID 60996
Premarket Approval
PMA Number
P060019
Product Classification Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter - Product Code OAD
Product The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.
Code Information T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.
Recalling Firm/
Manufacturer
St Jude Medical Inc
177 E County Road B
Saint Paul, Minnesota 55117-1951
Manufacturer Reason
for Recall
Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control
Action The notification letter was dated January 5th, 2012 and titled "Product Recall RF Generator 1500T9-CP". The letter informed customers that a St Jude Medical 1500T9-CP RF Generator unit had been distributed to them while currently under FDA review as part of a PMA supplement application. The letter requested that the use of the impacted generator be discontinued. Customers were requested to return the field action form and return the unit identified in the letter. The contact number provided in the letter is: 651-756-2000.
Quantity in Commerce 2 units
Distribution Nationwide Distribution, including the states of Kansas and Maryland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = OAD and Applicant = IRVINE BIOMEDICAL, INC.
PMAs with Product Code = OAD and Applicant = ST. JUDE MEDICAL
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