FDA recall, , Moderate risk
Boston Scientific Neuromodulation Nalu Neurostimulation System Therapy Disc and Patient Kit
The Therapy Disc has a firmware issue that causes it to attempt to restart, then fail, becoming non-functional.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Neuromodulation Corporation, of Valencia, California, voluntarily began a recall on September 30, 2026, of the Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and the TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System.
The Therapy Disc powers and sends stimulation signals to an Implantable Pulse Generator, and a firmware issue causes the disc to attempt to restart, then fail, becoming non-functional. If a secondary Therapy Disc is unavailable, this may lead the Implantable Pulse Generator to become non-functional, thus unable to inhibit transmission of pain signals.
The recall was added to the FDA's Enforcement Report on October 29, 2026, and classified the same day. Distribution was nationwide in the states of Arizona, California, Florida, Michigan, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina and Texas.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its serial number is listed.
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
- Serial number
- 34014-001
- 00812537037134
- 100855
- 100877
- 100883
- 100884
- 100886
- 100888
- 100898
- 100903
- 100908
- 100911
- 100916
- 100932
- 101103
- 100902
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
US Nationwide distribution in the states of Pennsylvania, Florida, Oregon, Arizona, Ohio, South Carolina, Texas, Oregon, Oklahoma, Michigan, California, New Jersey.
- Recalled by
- Boston Scientific Neuromodulation CorporationValencia, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99785
- Recall number
- Z-0311-2027
- Recall type
- Voluntary: Firm initiated
All recalls from Boston Scientific Neuromodulation Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Boston Scientific Neuromodulation Corporation began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
