Medtronic Micra Transcatheter Pacemaker System

Medtronic, Inc.

Not determinedIndexed from FDA records

We found your device, but we don't have its MRI instructions yet. Good news: most modern implants can be scanned when the right steps are followed, and your MRI team verifies every device 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

We don’t have this device’s MRI instructions yet. Most modern implants can be scanned when the right steps are followed. Your MRI team verifies every device 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 II — Moderate

Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

8/5/2019 · 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

Cardiac Pacemakers

Body Region

Chest

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