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 corpus and the live FDA recall database.
- Total reports
- 8,981
- Deaths
- 210
- Injuries
- 4,034
- Malfunctions
- 4,734
Reports per year
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-07-17Open, ClassifiedUnder Investigation by firm
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- 2026-07-17Open, ClassifiedUnder Investigation by firm
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- 2026-07-17Open, ClassifiedUnder Investigation by firm
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- 2026-07-17Open, ClassifiedUnder Investigation by firm
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- 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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