PlainRecordsNalu TD2 Therapy Disc with firmware…
- Reason
- 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…
- Status
- Ongoing
- Distribution
- US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
- Enforcement report date
- Nov. 4, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- 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
- Reason
- 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.
- Distribution pattern
- US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
- Quantity
- 134
- 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
- Recall started
- Sept. 30, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- Z-0311-2027
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System, FDA enforcement report, 2026-11-04. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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Distributed in (FDA's record): Arizona California Florida Michigan New Jersey Ohio Oklahoma Oregon Pennsylvania South Carolina Texas and nationwide
This recall among the others
- FDA's enforcement report came 35 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
- Boston Scientific Neuromodulation: 9 other recalls or notices on this site in the three years before this one (from Nov. 5, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0311-2027. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0311-2027, Nov. 4, 2026. "Nalu TD2 Therapy Disc with firmware." PlainRecords, https://plainrecords.com/recall/device/z-0311-2027/ (on this site since Nov. 11, 2026; as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections