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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Electrophysiology: Ablation

MAUDE Lookup Electrophysiology: AblationPOLARx

POLARx Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Aug 2023

Total Reports

229

Reports (30d)

1

Active Signals

1

Open Recalls

7

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

High Force Reading with Pericardial Effusion

micro, qdot micro, pericardial, effusion, qdot

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Evidence

Related research

Procedural Safety and Efficacy for Pulmonary Vein Isolation with the Novel Polarx™ Cryoablation System: A Propensity Score Matched Comparison with the Arctic Front™ Cryoballoon in the Setting of Paroxysmal Atrial Fibrillation

Dhanunjaya Lakkireddy · Journal of Atrial Fibrillation · 2020

PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF

Tobias Reichlin, et al. · JACC. Clinical electrophysiology · 2024

Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience

Nikita Tanese, et al. · EP Europace · 2023

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

Denise Guckel, et al. · Journal of Cardiovascular Development and Disease · 2022

Cryoballoon atrial fibrillation ablation: Single‐center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform

Adriano Nunes Kochi, et al. · Journal of Cardiovascular Electrophysiology · 2021

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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.