Medtronic Soletra

Medtronic, Inc.

MR UnsafeIndexed from FDA records

What this means for you

MR Unsafe — do not bring into the MRI scanner room. This device cannot safely be in the MRI suite. If a scan is essential, your physician will discuss alternatives.

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

✅This recall has been resolved

⚠️

FDA Recall Alert

Class I — Most Serious

Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

💡 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.

6/24/2007 · 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) NumberK031917 ↗

Clearance Date8/18/2003

Product CodeFPA

✅

All Recalls Resolved

1 past recall — all corrective actions completed

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

MRI Conditions

Legacy device. NOT MRI conditional.

Clinical Warnings

WARNING: Legacy DBS. MRI is CONTRAINDICATED.

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