Drug recall
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8…
FDA recall event 94682 · Class II · Nalu Medical, Inc.
Key facts
| Event ID | 94682 |
|---|---|
| Recall numbers | Z-2257-2024 |
| Recalling firm | Nalu Medical, Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 3, 2024 |
| Report date | Jul 10, 2024 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3015425075 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: