Recall Z-2602-2016 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
| Date | Jun 10, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 70 |
| Distribution | US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.