CoreValve Evolut PRO+

Medtronic, Inc.

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.
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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

No 510(k) clearance data available for this device.

✅
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.

Category

Heart Valves and Annuloplasty Rings

Body Region

Heart

MRI Conditions

MR Conditional at 1.5T and 3T. Self-expanding TAVR valve. Nitinol frame with porcine pericardial tissue. Non-ferromagnetic.

Clinical Warnings

Delivery system is NOT MRI-conditional. MRI scans are only safe AFTER the valve has been fully implanted and the delivery catheter has been completely removed from the body.

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