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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 LookupElectrophysiology: AblationNA

NA Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Cardiac Ablation Catheter (Percutaneous) · First cleared Apr 2003

Total Reports

103

Reports (30d)

0

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Irrigation Failure with Pericardial Effusion

pericardial effusion, flow, pericardial, effusion, pericardiocentesis

2

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

Evidence

Related research

Efficacy and Safety of Sacubitril/Valsartan Versus Enalapril in the Treatment of Heart Failure With Reduced Ejection Fraction: A Systematic Review and Meta-Analysis.

Aljubeh R, et al. · 2026

Unplanned Mechanical Circulatory Support as Hemodynamic Rescue Worsens Outcomes in Transcatheter Aortic Valve Replacement.

Keller M, et al. · 2026

"Ten Optimal Physiological Parameters" to keep the patient safe perioperatively: A narrative review.

Çekmen N, et al. · 2026

Effect of SGLT2 inhibitors on heart failure outcomes in patients with and without diabetes: A systematic review and meta-analysis of randomized controlled trials.

Bafail DA, et al. · 2026

Interventional Endoscopy for the Management of Post-Surgical Leaks and Fistulas: A Scoping Review.

Pessarelli T, et al. · 2026

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.

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How a safety signal is detected

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

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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.