Nalu Medical recalls Neurostimulation Kits with potential reduced pain signal inhibition due to manufacturing issues. Affected units may not function properly, causing pain signals to bypass the device.
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.
Nalu Medical is recalling certain Neurostimulation Kits that may not function properly, leading to pain signals bypassing the device. This could result in inadequate pain management for users.
The device may have manufacturing issues that reduce radiofrequency signal efficiency between the implantable pulse generator and therapy disc. This can cause the device to become non-functional, meaning it no longer inhibits pain signals to the brain.
Users of the recalled Neurostimulation Kits who require pain management through spinal cord stimulation. Patients with spinal cord conditions are most at risk of reduced pain control.
Check for the model name 'Neurostimulation Kit (Ported, Dual 8, 40 cm)' and serial numbers H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431.
Look for serial numbers H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431 on the device packaging or label.
The recalled model is Neurostimulation Kit (Ported, Dual 8, 40 cm) with serial numbers H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431.
The device has a manufacturing issue that may reduce radiofrequency signal efficiency between the implantable pulse generator and therapy disc, causing the device to become non-functional and not inhibit pain signals.
Check your device serial numbers against the list provided. If you have a recalled unit, contact Nalu Medical for further instructions.
We’ve drafted a message you can send Nalu to request your refund or repair — edit it as you like.
Subject: Recall Z-2257-2024 — Nalu Nalu Hello, I own a Nalu that is covered by recall Z-2257-2024 from Nalu. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
