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Boston Scientific Neuromodulation Corporation recalls Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS)
Recalled June 3, 2020 · FDA recall Z-2125-2020 · Boston Scientific Neuromodulation
Hazard
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue. · FDA Class II
Units
8 units
Sold at
Distributed OUS only. to 14 countries.
Description
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Product
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication.
Manufacturer(s)
Boston Scientific Neuromodulation Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →