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 M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. 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
Quantity: 41 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