Class 3 Device Recall CapSureFix

• Date Initiated by Firm: October 20, 2004
• Date Posted: November 17, 2004
• Recall Status: Terminated 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)
• FEI Number: 2182208
• 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: 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.