Nalu Neurostimulation System

Nalu Medical

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
Sign in to save implants to your account

For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

6/2/2024 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

510(k) NumberK183047 ↗
Clearance Date3/21/2019
Product CodeGZB
⚠️1 Active Recall

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Neuro

Body Region

Spinal Cord Stimulators

MRI Conditions

MRI conditional. External components MUST be removed. Only internal lead/anchor/micro-IPG approved.

Clinical Warnings

Remove ALL external components before MRI. Only implanted components are MRI conditional.

Post-MRI Notes

Interrogate device after MRI to verify settings.

🔔 Get Recall Alerts for Nalu Neurostimulation System
Get notified if the FDA issues a recall for this specific implant

Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.