Date Initiated by Firm | November 11, 2002 |
Create Date | June 25, 2015 |
Recall Status1 |
Terminated 3 on July 02, 2004 |
Recall Number | Z-0351-03 |
Recall Event ID |
25150 |
510(K)Number | K013392 |
Product Classification |
unknown device name - Product Code 74
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Product | Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47 |
Code Information |
Lot number 2002080004 |
Recalling Firm/ Manufacturer |
Medtronic Cardiac Surgery Technologies 7601 Northland Drive Minneapolis MN 55428
|
Manufacturer Reason for Recall | The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device. |
FDA Determined Cause 2 | Other |
Action | A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives. |
Quantity in Commerce | 148 pens |
Distribution | All of the consignees were in foreign countries in Europe, Asia and Latin America. |
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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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510(K) Database | 510(K)s with Product Code = 74
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