SAPIEN 3 Ultra RESILIA

Edwards Lifesciences

Life-sustaining device
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.

Device specifications

SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm

Device type (GMDN)Aortic transcatheter heart valve bioprosthesis, stent-like framework
SterilizationNot sterilized prior to use

FDA adverse-event reports

1,854 safety reports filed with the FDA for this device type.

This is the FDA's own count across all devices sharing this product code — not specific to your device, and not a measure of your device's safety.

View on FDA →

Counts as of 7/5/2026

Manufacturer contact

Phone+1(800)822-9637

Regulatory Info

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

✅No Recalls Found

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 Scan Parameters

Max Field Strength3.0T

MRI Conditions

MR Conditional at 1.5T and 3.0T.

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