Boston Scientific Nalu Therapy Disc Firmware Defect Recall
Boston Scientific is recalling 134 Nalu Therapy Discs and Patient Kits due to a firmware issue that may cause the device to become non-functional, potentially stopping pain signal inhibition.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II because the firmware failure may cause the neurostimulation system to stop working, potentially allowing pain signals to be transmitted, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling 134 units of the Nalu TD2 Therapy Disc with firmware (REF: 34014-001) and TD2 Patient Kit (REF: 74011). These components are part of the Nalu Neurostimulation System, which includes a Therapy Disc that powers and sends stimulation signals to an Implantable Pulse Generator (IPG).
The recall is due to a firmware issue that causes the Therapy Disc to attempt to restart and then fail, leading it to become non-functional. If a secondary Therapy Disc is unavailable, this failure may cause the IPG to become non-functional, rendering it unable to inhibit the transmission of pain signals.
The affected units were distributed nationwide in the states of Pennsylvania, Florida, Oregon, Arizona, Ohio, South Carolina, Texas, Oklahoma, Michigan, California, and New Jersey. The specific firmware versions involved are v2.0.71 and v2.0.77. Patients and healthcare providers should contact Boston Scientific or their healthcare provider for instructions on how to address this issue.
The recalled product
- Product
- Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Affected units
- 134
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 100877
- 100883
- 100884
- 100886
- 100888
- 100898
- 100903
- 100908
- 100911
- 100916
- 100932
- 101103
- 100902
- 74011/00812537037127
- 00812537036977/101439
- 100913
- 100949
- 101159
- 101162
- 101163
Distribution
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