Class 2 Device Recall Medtronic DBS

• Date Initiated by Firm: April 16, 2007
• Date Posted: June 15, 2007
• Recall Status: Terminated on February 24, 2008
• Recall Number: Z-0934-2007
• Recall Event ID: 37847
• PMA Number: P960009S036
• Product Classification: Deep Brain Stimulation Lead Kit - Product Code MHY
• Product: Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604
• Code Information: V026775
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 800 53rd Ave NE; PO Box 1250; Minneapolis MN 55440-1250
• For Additional Information Contact: 763-514-5174
• Manufacturer Reason for Recall: Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).
• FDA Determined Cause: Other
• Action: Medtronic field personnel visited affected customers and retrieved product from this lot, unless the product was needed for an imminent scheduled surgery. Telephone scripts and leave behind letters to each consignee were initiated in April 2007.
• Quantity in Commerce: 31 kits
• Distribution: Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.
• 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.

• PMA Database: PMAs with Product Code = MHY