Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Recalled by St. Jude Medical, Inc. Due to The Directions for Use (DFU) manual contains information...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical, Inc. directly.
Affected Products
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.
Quantity: 4 units
Why Was This Recalled?
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.
Where Was This Sold?
Distributed in the states of Texas and Illinois.
About St. Jude Medical, Inc.
St. Jude Medical, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report