Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
This recall has been terminated (originally issued June 10, 2016).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- June 10, 2016
- Terminated
- October 3, 2016
- Recall Number
- Z-2602-2016
- Quantity
- 70
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
Lot / Code Info
lots: VA15GPJ, VA15K3N, VA15K7K
Root Cause
Process design
Action Taken
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.