Class 2 Device Recall Medtronic

• Date Initiated by Firm: November 11, 2002
• Create Date: June 25, 2015
• Recall Status: Terminated 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: 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