FDA Device recall Z-1617-2015
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086 by Medtronic Neuromodulation, citing medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 370….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1617-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Reason
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
Identifiers
| code_info | all Serial numbers |
|---|
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-1617-2015%22
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