Recall Z-3069-2017 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant proced
| Date | Mar 17, 2017 |
| Status | Terminated |
| Reason | Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target. |
| Root cause | Process control |
| Action | Medtronic sent an Urgent Medical Device Correction letter dated March 2017, to all affected consignees with important safety information on the use of the device. No product retrieval is involved at this time. The letter was addressed to Neurosurgeon. The letter described the product involved in the recall, provided information on the "Background", "Potential Risk to Patients", "Actions", & "Additional Information". For questions, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - pm CDT. |
| Quantity | 86,024 |
| Distribution | Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Foreign Distribution: India, ANZ, Taiwan, Hong Kong, Canada, Chin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.