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U.S. Department of Health and Human Services

Class 3 Device Recall CapSureFix

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  Class 3 Device Recall CapSureFix see related information
Date Initiated by Firm October 20, 2004
Date Posted November 17, 2004
Recall Status1 Terminated 3 on January 24, 2005
Recall Number Z-0207-05
Recall Event ID 30369
PMA Number P930039S009 
Product Classification Tester, Pacemaker Electrode Function - Product Code DTA
Product Medtronic CapSureFix Novus Lead Model 5076.
Code Information Model 5076 45 cm leads (PJN631011V and PJN631012V)
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Fridley MN 55432
Manufacturer Reason
for Recall		 A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.
FDA Determined
Cause 2		 Other
Action Letter of October 20, 2004, to direct customers, advised them to work with their respective Medtronic representatives to locate all leads and return them to Medtronic.
Quantity in Commerce 35 incorrectly labeled leads were distributed to customers.
Distribution Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.
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.
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