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U.S. Department of Health and Human Services

Class 2 Device Recall Neurostimulation Kit (Ported, Dual 8, 40 cm)

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 Class 2 Device Recall Neurostimulation Kit (Ported, Dual 8, 40 cm)see related information
Date Initiated by FirmJune 03, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2257-2024
Recall Event ID 94682
510(K)NumberK183047 K183579 
Product Classification Stimulator, peripheral nerve, implanted (pain relief) - Product Code GZF
ProductNeurostimulation 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.
Code Information 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
FEI Number 3015425075
Recalling Firm/
Manufacturer		 Nalu Medical, Inc.
2320 Faraday Ave Ste 100
Carlsbad CA 92008-7216
For Additional Information Contact
760-448-2360
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce13
DistributionUS Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GZF
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