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Class 2 Device Recall Medtronic, Lead Kit for DBS Stimulation |
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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
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Product |
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
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Code Information |
lots: VA15GPJ, VA15K3N, VA15K7K |
Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 7000 Central Ave Minneapolis MN 55421-1241
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For Additional Information Contact |
Medtronic Technical Services 800-707-0933
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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.
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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
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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.
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PMA Database |
PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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