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U.S. Department of Health and Human Services

Class 2 Device Recall NaluTM Neurostimulation Therapy Disc

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 Class 2 Device Recall NaluTM Neurostimulation Therapy Discsee related information
Date Initiated by FirmSeptember 30, 2026
Date PostedOctober 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0311-2027
Recall Event ID 99785
510(K)NumberK233801 
Product Classification Stimulator, spinal-cord, implanted (pain relief) - Product Code GZB
ProductNalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Code Information Firmware versions v2.0.71 and v2.0.77 REF/UDI-DI/Serial Numbers: 34014-001/00812537037134/ 100855, 100877, 100883, 100884, 100886, 100888, 100898, 100903, 100908, 100911, 100916, 100932, 101103, 100902; 74011/00812537037127, 00812537036977/101439, 100913, 100949, 101159, 101162, 101163, 101164, 101173, 101175, 101177, 101186, 101187, 101188, 101189, 101192, 101200, 101205, 101208, 101213, 101214, 101218, 101219, 101221, 101222, 101240, 101245, 101247, 101249, 101256, 101257, 101259, 101260, 101261, 101264, 101267, 101268, 101270, 101272, 101273, 101277, 101278, 101280, 101283, 101284, 101290, 101297, 101298, 101301, 101305, 101307, 101310, 101311, 101312, 101314, 101315, 101326, 101330, 101331, 101334, 101338, 101344, 101345, 101346, 101356, 101357, 101358, 101359, 101363, 101364, 101367, 101375, 101376, 101377, 101378, 101381, 101383, 101387, 101388, 101392, 101400, 101405, 101408, 101410, 101414, 101415, 101417, 101418, 101419, 101429, 101431, 101432, 101436, 101440, 101441, 101443, 101447, 101448, 101450, 101451, 101466, 101490, 101493, 101504, 101510, 101511, 101514, 101520, 101527, 101528, 101534, 101535, 101553, 101557, 101567, 101571, 101576, 101599, 101617, 101623, 101656
FEI Number 3006630150
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information ContactRenee Archie
508-683-4523
Manufacturer Reason
for Recall		Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is unavailable, this may lead IPG to become non-functional, thus unable to inhibit transmission of pain signals.
FDA Determined
Cause 2		Software change control
ActionOn 9/30/2026, correction notices will be sent to healthcare professionals informing them of the following: Patients are provided with two TDs at the time of therapy activation, so therapy can be restored with the use of an alternate TD. The firm is asking healthcare professionals to do the following: 1) Identify the affected patients and inform them of this recall to arrange an-field TD firmware update. All affected units should be updated with the new firmware. Patient letter is provided with this notification for your use. 2) Contact the local firm representative to arrange an in-field TD firmware update at your facility. Append the patient's medical record accordingly when the firmware update is completed. 3) Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred. 4) Complete and return the Acknowledgement Form via email to BSCFieldActionCenter@bsci.com The patient notice recommended that patients contact their physician's office so they can arrange an in-field TD firmware update with the local firm representative. If they have any questions after contacting their doctor, contact the firm's Patient Care at 800-618-3402 or BSNPatientCare@bsci.com. Report any adverse events or quality concerns associated with use of these devices to the firm via email at BSCComplaints@bsci.com
Quantity in Commerce134
DistributionUS Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
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 = GZB
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