FDA Device recall Z-3069-2017
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead…
- FDA Device
- Class II
- terminated
- Published 2017-08-30
On 2017-08-30 the FDA classified a Class II recall of DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead… by Medtronic Neuromodulation, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3069-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-17 |
| Published | 2017-08-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Model 3387, Lot Serial #: 0206880294, 0206882647, 0206882779, 0206882780, 0206882781, 0206882782, 0206882783, 02068861…Model 3387, Lot Serial #: 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, 0206916393, 0206916394, 0206916395, 0206916396, 0206916397, 0206916398, 0206916399, 0206916797, 0206917120, 0206917121, 0206917122, 0206917123, 0206917124, 0206917125, 0206917126, 0206917127, 0206917128, 0206917129, 0206917130, 0206917131, 0206917132, 0206917302, 0206917303, 0206917304, 0206917306, 0206917307, 0206917308, 0206917310, 0206917312, 0206917560, 0206917561, 0206917563, 0206917564, 0206917565, 0206917566, 0206917568, 0206917569, 0206917570, 0206917572, 0206917573, 0206917574, 0206917575, 0206917576, 0206917577, 0206917578, 0206917579, 0206917620, 0206917621, 0206917622, 0206917623, 0206917624, 0206917625, 0206917626, 0206917627, 0206917628, 0206917629, 0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3069-2017%22
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