Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fifty-five (55) cm 8 Contact Extension Kit Recalled by Boston Scientific Neuromodulation Corporation Due to The firm is initiating a voluntary removal of...
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 Boston Scientific Neuromodulation Corporation directly.
Affected Products
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.
Quantity: 8 units
Why Was This Recalled?
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.
Where Was This Sold?
Distributed OUS only. to 14 countries.
About Boston Scientific Neuromodulation Corporation
Boston Scientific Neuromodulation Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report