Medtronic — Class II medical device recall Z-2602-2016
Terminated recall by Medtronic Neuromodulation, reported 2016-08-31, distributed in AR, CA, FL, IL, MD, MO, NE, NY…. Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufact
| Recall number | Z-2602-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2016-06-10 |
| Classified | 2016-08-19 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2016-10-03 |
| Distributed | AR, CA, FL, IL, MD, MO, NE, NY, OH, TN, WI |
| Quantity | 70 |
| Lot numbers | VA15GPJ, VA15K3N, VA15K7K |
| Model numbers | 3387S-40 |
Product
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Reason for recall
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.
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-2602-2016. 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.