DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation — Class II medical device recall Z-3069-2017
Terminated recall by Medtronic Neuromodulation, reported 2017-08-30, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in
| Recall number | Z-3069-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2017-03-17 |
| Classified | 2017-08-23 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2021-04-22 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AT, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, PA, PE, PH, PK, PL, PT, RO, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 86,024 |
| Serial numbers | 0206880294, 0206882647, 0206882779, 0206882780, 0206882781, 0206882782, 0206882783, 0206886184, 0206886323, 0206886328, 0206886330, 0206886331, 0206886332, 0206886333, 0206886603, 0206887813, 0206890443, 0206890444, 0206903488, 0206903489, 0206906792, 0206906793, 0206907159, 0206916391, 0206916392 and 475 more |
| Model numbers | 3387, 3387/3387S, 3389/3389S, 3391/3391S |
Product
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 procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3069-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.