Home › Device types › QZI
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA product code QZI · Class 3 · Unknown
106
Registered devices
8,980
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
FARASTAR™ — BOSTON SCIENTIFIC CORPORATIONCurrent™ — ST. JUDE MEDICAL, INC.FARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARAWAVE™ — BOSTON SCIENTIFIC CORPORATIONPulseSelect™ — MEDTRONIC, INC.FARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONHexaGen™ RF Generator — MEDTRONIC, INC.Current™ — ST. JUDE MEDICAL, INC.FARASTAR™ — BOSTON SCIENTIFIC CORPORATIONHexaFlow™ Irrigation Pump — MEDTRONIC, INC.FARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONSphere-9™ Catheter — MEDTRONIC, INC.FARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONFARASTAR™ — BOSTON SCIENTIFIC CORPORATIONCurrent™ — ST. JUDE MEDICAL, INC.Sphere-9™ Catheter — MEDTRONIC, INC.FARASTAR™ — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-11 | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| 2026-06-11 | Boston Scientific Corporation | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. |
| 2026-06-11 | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| 2026-06-11 | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| 2025-06-25 | Boston Scientific Corporation | The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end. |
| 2025-01-05 | Biosense Webster, Inc. | Due to an observed trend of neurovascular events |
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