Z-2257-2024Class II

Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8...

Name: Z-2257-2024 Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8...
Creator: Nalu Medical, Inc.
Published: 2024-06-03
License: https://open.fda.gov/license/

Nalu Medical / initiated 2024-06-03 / Open, Classified / root cause: manufacturing process

FDA source

Nalu Medical, Inc. began a recall of 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... on 2024-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2257-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-07-03
Recalling firm: Nalu Medical
Product: 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.
Product code: GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected] 5) If you have any questions, please call your local sales representative at (480) 313-9745.
Quantity in commerce: 13
Distribution: US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
Product codes and lots: UDI-DI: 71005-US: 00812537036137, 00812537033600, 00812537033518, 00812537030975, 00812537030524. 71019-US: 00812537036441, 00812537035604, 00812537035598 Serial Numbers: H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2257-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2257-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code GZF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)