Medtronic DBS Lead Kit for Deep Brain Stimulation — Class I medical device recall Z-1190-2013
Terminated recall by Medtronic Neuromodulation, reported 2013-05-08, distributed nationwide. There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtron
| Recall number | Z-1190-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2013-02-08 |
| Classified | 2013-05-01 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, 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, IE, IL, IN, IS, IT, JO, JP, KR, LB, LK, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, PE, PH, PL, PT, RO, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 30,000 |
| Model numbers | 3387, 3387S, 3389, 3389S, 3391, 3391S |
Product
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinsons Disease (PD), and epilepsy.
Reason for recall
There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag
Machine access
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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.