Z-0311-2027

Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu...

Name: Z-0311-2027 Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2026-09-30
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2026-09-30 / Open, Classified

FDA source

Recall record

Recall number: Z-0311-2027
Status: Open, Classified
Initiated: 2026-09-30
Posted: 2026-10-29
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Product code: GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
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 root cause: Software change control
Action: On 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 [email protected] 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 [email protected]. Report any adverse events or quality concerns associated with use of these devices to the firm via email at [email protected]
Quantity in commerce: 134
Distribution: US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
Product codes and lots: 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

Product code GZB

K233801Class IINalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation / cleared 2024-08-23

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-03. View this recall on fda.gov (opens on fda.gov)