Percutaneous Trial Lead Kit Model 3086 — Class II medical device recall Z-2719-2014
Terminated recall by St. Jude Medical, Inc., reported 2014-10-08, distributed in IL, TX. The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The corr
| Recall number | Z-2719-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Inc., Plano, TX, United States |
| Recall initiated | 2014-07-29 |
| Classified | 2014-09-29 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2015-08-21 |
| Distributed | IL, TX |
| Quantity | 4 units |
| Reason classes | unapproved product |
| Lot numbers | 4519182 |
| Model numbers | 3086 |
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 for recall
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.
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-2719-2014. 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.