CLASS II ONGOING Device recall · Reported 4 Nov 2026 · FDA Enforcement Report
Nalu TD2 Therapy Disc with firmware recalled by Boston Scientific
Boston Scientific Neuromodulation is recalling Nalu TD2 Therapy Disc with firmware, distributed nationwide in the US. The recall was initiated on 30 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0311-2027
- FDA event ID
- 99785
- Recalling firm
- Boston Scientific Neuromodulation, Valencia, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2026
- FDA classified
- 29 Oct 2026
- Reported
- 4 Nov 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 30 Sep 2026 | Recall initiated by company | |
| 29 Oct 2026 | Classified by FDA | +29 days |
| 4 Nov 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Where it was distributed
US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
Nationwide ArizonaCaliforniaFloridaMichiganNew JerseyOhioOklahomaOregonPennsylvaniaSouth CarolinaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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