Nalu Neurostimulation Kits Recalled for Manufacturing Defect and Device Failure
Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a manufacturing defect causing device non-functionality. While no deaths or injuries have been reported, the defect prevents the neurostimulation system from performing its intended therapeutic function, representing a risk of harm through inadequate pain management in affected patients.
Plain-English summary
Nalu Medical, Inc. is recalling 13 neurostimulation kits that are components of the Nalu Spinal Cord Stimulation System. The affected products are the Neurostimulation Kit (Ported, Dual 8, 40 cm, REF: 71005-US) and Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm, REF: 71019-US).
The recall is due to a manufacturing non-conformance affecting the radiofrequency signal pathway between the implantable pulse generator (IPG) and the therapy disc. This defect may reduce the efficiency of radiofrequency signals, causing the IPG to become non-functional. When the device fails, it can no longer inhibit the transmission of pain signals to the brain.
The affected units were distributed nationwide in Missouri, Illinois, California, Texas, Tennessee, Oklahoma, Arizona, and Arkansas. Healthcare providers and patients with these devices should contact Nalu Medical for instructions on appropriate next steps.
The recalled product
- Product
- Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
- Manufacturer
- Nalu Medical, Inc.
- Affected units
- 13
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 (19)
- UDI-DI: 71005-US: 00812537036137
- 00812537033600
- 00812537033518
- 00812537030975
- 00812537030524. 71019-US: 00812537036441
- 00812537035604
- 00812537035598 Serial Numbers: H01377
- H01382
- H01432
- H01419
- H01387
- H01445
- H01415
- H01441
- H01373
- H01428
- H01378
- H01438
- H01431
Distribution
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