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St. Jude Medical, Inc. recalls Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulatio
Recalled October 8, 2014 · FDA recall Z-2719-2014 · St. Jude Medical
Hazard
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. · FDA Class II
Units
4 units
Sold at
Distributed in the states of Texas and Illinois.
Description
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.
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.
Manufacturer(s)
St. Jude Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →