Carlsbad, CA, United States
Nalu Medical, Inc. recalls
1 recall recorded since 2018, most recently on 3 June 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 June 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2257-2024
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.