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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DBS

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 Class 2 Recall
Medtronic DBS
see related information
Date Posted June 15, 2007
Recall Status1 Terminated on February 24, 2008
Recall Number Z-0934-2007
Recall Event ID 37847
Premarket Approval
PMA Number
P960009/S036
Product Classification Stimulator, Electrical, Implanted, For Parkinsonian Tremor - 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, Minnesota 55440-1250
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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MHY and Applicant = MEDTRONIC VASCULAR
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