Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA adverse event reports and recall history for percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation (product code QZI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 8,451
- Deaths
- 201
- Injuries
- 3,756
- Malfunctions
- 4,491
Reports per year
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-08-08Open, ClassifiedNonconforming Material/Component
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
- 2025-02-28Open, ClassifiedLabeling design
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
Due to an observed trend of neurovascular events
Monitor percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation automatically
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