FDA Device recall Z-2602-2016
Medtronic, Lead Kit for DBS Stimulation
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Medtronic, Lead Kit for DBS Stimulation by Medtronic Neuromodulation, citing 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 com….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2602-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-10 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | AR, CA, FL, IL, MD, MO, NE, NY, OH, TN, WI |
Product
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
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.
Identifiers
| code_info | lots: VA15GPJ, VA15K3N, VA15K7K |
|---|
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-2602-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.