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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DBS

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  Class 2 Device Recall Medtronic DBS see related information
Date Initiated by Firm April 16, 2007
Date Posted June 15, 2007
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDTRONIC Inc.
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