Arctic Front Advance Pro Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Dec 2010

Total Reports

1,696

Reports (30d)

15

Active Signals

2

Open Recalls

1

Monthly Report Volume
Event Type Breakdown

Active safety signals

Disproportionate reportinghighIncreasing trendcritical

FDA recalls for this device

Class III

Mar 4, 2019 · Open, Classified

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.