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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Lead Kit for DBS Stimulation

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  Class 2 Device Recall Medtronic, Lead Kit for DBS Stimulation see related information
Date Initiated by Firm June 10, 2016
Create Date August 19, 2016
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-2602-2016
Recall Event ID 74545
PMA Number P960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Code Information lots: VA15GPJ, VA15K3N, VA15K7K
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave
Minneapolis MN 55421-1241
For Additional Information Contact Medtronic Technical Services
800-707-0933
Manufacturer Reason
for Recall		 Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
FDA Determined
Cause 2		 Process design
Action Consignees were delivered in person by Medtronic Field Representatives a "Medical Device Removal" letter dated June 2016. The letter described the problem and the product involved in the recall. Advised consignees to return the unused product and to complete the Customer Confirmation Form. For questions contact Medtronic Technical Services at 800-707-09033 weekdays 7 am - 6 pm, or contact your Medtronic representative.
Quantity in Commerce 70
Distribution US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
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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