In the agency's Nov 4, 2026 enforcement report · Ongoing
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation…
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- Nalu TD2 Therapy Disc with firmware
- REF
34014-001and TD2 Patient Kit
- REF74011, part of the Nalu Neurostimulation System
- Lot codes and dates
- Firmware versions v2.0.71 and v2.0.77
- REF/UDI-DI/Serial Numbers
135 of 135 codes
34014-001/00812537037134/ 10085510087710088310088410088610088810089810090310090810091110091610093210110310090274011/0081253703712700812537036977/101439100913100949101159101162101163101164101173101175101177101186101187101188101189101192101200101205101208101213101214101218101219101221101222101240101245101247101249101256101257101259101260101261101264101267101268101270101272101273101277101278101280101283101284101290
- Amount recalled
- 134
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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