Date Initiated by Firm | January 05, 2012 |
Date Posted | February 14, 2012 |
Recall Status1 |
Terminated 3 on September 04, 2014 |
Recall Number | Z-1032-2012 |
Recall Event ID |
60996 |
PMA Number | P060019 |
Product Classification |
Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
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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 MN 55117-1951
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For Additional Information Contact | 651-756-6526 |
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 | 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 |
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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.
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PMA Database | PMAs with Product Code = OAD
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