FDA Device recall Z-2719-2014
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead)
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead) by St Jude Medical, citing the Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2719-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-29 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical |
| Distribution | IL, TX |
Product
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Reason
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
Identifiers
| code_info | Material 100077108, Batch 4519182 |
|---|
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-2719-2014%22
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