AVEIR Leadless Pacemaker (VR / DR / DR I2I)
Abbott
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:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- 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:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- 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.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
FDA Recall Alert
Class II — ModerateTheir is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
💡 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.
2/4/2024 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousTheir is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
💡 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.
2/4/2024 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousDue to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
💡 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.
2/14/2025 · View on FDA.gov
FDA Recall Alert
Class II — ModerateDue to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
💡 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.
2/14/2025 · 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.
Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.
Category
Cardiac Pacemakers
Body Region
Heart
MRI Scan Parameters
MRI Conditions
MR Conditional at 1.5T and 3.0T. AVEIR DR i2i is the dual-chamber system pairing one VR (right ventricle) and one AR (right atrium) leadless pacemaker.
Clinical Warnings
Mandatory programming: device must be programmed to MRI Mode by a physician or clinician BEFORE the scan to prevent interference or unintended stimulation, and reverted afterward.
Post-MRI Notes
Interrogate device after MRI.
Tracked Settings
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.