St. Jude Medical, Inc. 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
St. Jude Medical, Inc.
Lot Codes / Batch Numbers
Material 100077108, Batch 4519182
Products Sold
Material 100077108, Batch 4519182
St. Jude Medical, Inc. is recalling Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Med due to 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. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, IN, TX
Page updated: Jan 10, 2026