FDA Device recall Z-1191-2013
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339
- FDA Device
- Class I
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class I recall of Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339 by Medtronic Neuromodulation, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1191-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-02-08 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).
Reason
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
Identifiers
| code_info | all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Inst…all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1191-2013%22
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