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.
Reported: July 10, 2024 Initiated: June 3, 2024 #Z-2257-2024
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Nalu Medical, Inc.
- Units Affected
- 13
- Distribution
- US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
- Location
- Carlsbad, CA
Frequently Asked Questions
What product 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.. Recalled by Nalu Medical, Inc.. Units affected: 13.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2257-2024.
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