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U.S. Department of Health and Human Services

Class 2 Device Recall Enpath Lead Adapter

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  Class 2 Device Recall Enpath Lead Adapter see related information
Date Initiated by Firm September 01, 2009
Date Posted December 29, 2009
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-0580-2010
Recall Event ID 53777
510(K)Number K870562  
Product Classification Lead adapter, permanent pacemaker electrode - Product Code DTB
Product Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
Code Information Serial numbers: 148236, 148237, 148238, 148239, 148240, 148241, 148242, 148243, 148036, 148038, 148039, 148040, 148041, 148042, 148043, 148044, 148045, 148046, 148047, 148048, 148049, 148050, 148051, 148052, 148053, 148054, 148055, 148056, 148057, 148058, 148059, 148060, 148061, 148063, 148064, 148065, 148066, 148067, 148068, 148069, 148070, 148071, 148072, 148074, 148075. 
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Lane North
Minneapolis MN 55441
For Additional Information Contact
612-559-2613
Manufacturer Reason
for Recall		 The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
FDA Determined
Cause 2		 Component change control
Action Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.
Quantity in Commerce 45 units
Distribution CA and MN
Total Product Life Cycle TPLC Device Report
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 = DTB and Original Applicant = DAIG CORP.
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