Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), RE
FDA device recall Z-2257-2024 · posted 2024-07-03 · Open, Classified
Recall details
- Recalling firm
- Nalu Medical, Inc.
- 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.
- Action taken
- 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 cause similar product behaviors. If troubleshooting is unable to restore functionality, it is recommended that you make a clinical assessment around replacement surgery. Ultimately, the decision to act and/or communication with the patient will be at your discretion. 3) If you find a device that has been identified as part of the recalled product to be nonfunctional, you should notify us immediately through your local sales representative, our technical support line at (800) 618-3402 4) Complete and return the response form via email to regulatory@nalumed.com 5) If you have any questions, please call your local sales representative at (480) 313-9745.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- GZF
- Quantity affected
- 13
- Distribution
- US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
- Date initiated
- 2024-06-03
- Date posted
- 2024-07-03
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579) | Boston Scientific Neuromodulation | 2019-03-29 |
| Nalu Neurostimulation System (K183047) | Boston Scientific Neuromodulation | 2019-03-22 |