Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Neurostimulation Kit (Ported Recalled by Nalu Medical, Inc. Due to Neurostimulation Systems have a manufacturing non-conformance that may...
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 Nalu Medical, Inc. directly.
Affected Products
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Quantity: 13
Why Was This Recalled?
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nalu Medical, Inc.
Nalu Medical, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report