10,000 results
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49ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIPULSE CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC.·Product code QZI·September 12, 2024
FARAWAVE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·November 19, 2025
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code QZI·June 25, 2025
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.
FDA Recall
Open, Classified
·Biosense Webster, Inc.·Product code QZI·January 5, 2025
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·August 6, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·August 8, 2024
PULSESELECT
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code QZI·September 6, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·August 2, 2024
FARAWAVE PULSED FIELD ABLAT ION CATHETER, 31MM
FDA Adverse Event
Malfunction
·FARAPULSE, INC.·Product code QZI·July 18, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·September 9, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Injury
·FARAPULSE, INC.·Product code QZI·August 6, 2024
PULSESELECT
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code QZI·September 11, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·August 25, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·September 13, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Malfunction
·FARAPULSE, INC.·Product code QZI·September 6, 2024
FARAPULSE PULSED FIELD ABLATION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·September 13, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·August 9, 2024
PULSESELECT
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code QZI·August 13, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·July 24, 2024
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·July 11, 2024