Nalu Medical, Inc.: Device Recall
Recall #Z-2257-2024 · 06/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2257-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Nalu Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 06/03/2024
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
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.
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.
Distribution Pattern
US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.