Arctic Front Advance Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Dec 2010 · 2 device variants grouped
Total Reports
521
Reports (30d)
0
Active Signals
0
Open Recalls
1
Regulatory
FDA recalls for this device
Mar 4, 2019 · Open, Classified
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Evidence
Related research
Comparative efficacy and safety of POLARx versus Arctic front advance pro cryoballoon systems for pulmonary vein isolation in atrial fibrillation: an updated systematic review and meta-analysis.
Tahir MF, et al. · Frontiers in cardiovascular medicine · 2025
Ablation of atrial fibrillation using the fourth-generation cryoballoon Arctic Front Advance PRO.
Wissner E. · Future cardiology · 2020
Comparison of Arctic Front Advance Pro and POLARx cryoballoons for ablation therapy of atrial fibrillation: an intraprocedural analysis
Vincent Knappe, et al. · Clinical Research in Cardiology · 2024
Evaluation of the novel multi-points surface thermometry cryoballoon in the treatment of paroxysmal atrial fibrillation
Lu Bai, et al. · Frontiers in Cardiovascular Medicine · 2025
Citations indexed from PubMed.
Keep exploring
Related devices in Ablation
ThermoCool SmartTouch SF
Biosense Webster Inc · 5,902 reports
FARAWAVE
BOSTON SCIENTIFIC CORPORATION · 5,084 reports
TactiCath
ABBOTT (ST. JUDE MEDICAL) · 2,367 reports
PulseSelect
MEDTRONIC, INC. · 2,164 reports
Arctic Front Advance Pro
MEDTRONIC, INC. · 1,733 reports
QDOT MICRO
Biosense Webster Inc · 1,297 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data