Nalu Medical, Inc. recalls Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), R…

Recall date

June 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2257-2024

FDA classification

Class II

Brand / firm

Nalu Medical, Inc.

Sold / distributed

US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.