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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 FIT

POLARx FIT Adverse Events: FDA MAUDE Data

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

Total Reports

145

Reports (30d)

2

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

4

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

Impact of cryoballoon size adjustability on procedural and clinical outcomes.

Kikkoji N, et al. · 2025

Cryoballoon pulmonary vein isolation: Double stack vs standard ablation.

Kibel S, et al. · 2025

A randomized controlled trial of the size-adjustable cryoballoon vs conventional cryoballoon for paroxysmal atrial fibrillation: The CONTRAST-CRYO II trial rationale and design.

Kawamura I, et al. · 2024

Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study.

Schiavone M, et al. · 2024

Impact of Increased Cryoballoon Size on the Left Atrium, Superior Vena Cava, and Phrenic Nerve

Yukihiro Inamura, et al. · Journal of Cardiovascular Electrophysiology · 2025

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.