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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
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
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.
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.
510(K) Database 510(K)s with Product Code = 74 and Original Applicant = MEDTRONIC VASCULAR
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