Reported Jul 10, 2024 · Ongoing
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm),…
Nalu Medical, Inc.
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: Nalu Medical, Inc. · 2320 Faraday Ave Ste 100 · Carlsbad, CA · 92008-7216
Is this the product you have?
Neurostimulation Kit (PortedDual 840 cm)
- REF71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
- REF71019-US Components of the Nalu Spinal Cord Stimulation System
- Lot codes and dates
- UDI-DI
71005-US: 0081253703613700812537033600008125370335180081253703097500812537030524. 71019-US: 008125370364410081253703560400812537035598
- Serial Numbers
H01377H01382H01432H01419H01387H01445H01415H01441H01373H01428H01378H01438H01431
- UDI-DI
- Amount recalled
- 13
Where it was sold
Why it was recalled
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
This product could cause temporary or reversible health problems — stop using it.
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