Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thirty-five (35) 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
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.
Quantity: 19 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