Recall Z-2257-2024 ยท GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Nalu Medical, Inc.
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.
| Date | Jul 3, 2024 (initiated Jun 3, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 6/3/24, recall notices were mailed and emailed to Physicians managing patients with Implanted Pulse Generators (IPG) who were informed of the following: 1) Four of the IPGs have been found to have low RF efficiency readings. 2) Firm recommends monitoring the patients with IPGs with low RF efficiency readings through healthcare visits that occur to ensure proper functioning of the Neurostimulation Kit/Peripheral Nerve Stimulation Kit and working with your field representative to address any issues in the event the device is not performing as intended since there are other factors that could |
| Quantity | 13 |
| Distribution | US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR. |
| FDA record | Open on fda.gov |