Official recall record
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-09-30
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00812537037134
- Brand on record
- Boston Scientific Neuromodulation Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-11-13.
Record last checked against the registry on 2026-11-13.
Other recalls from this brand
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INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: S - 2025-07-08 · US FDA — Medical Devices
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise - 2025-07-08 · US FDA — Medical Devices
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
All 5 official recall notices naming Boston Scientific Neuromodulation Corporation on this site →
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