Boston Scientific Corporation: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Hazard

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Details from the source

Reason for recall: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. Distribution: International distribution in the countries of Italy, Austria, France, Germany, Belgium. Quantity: 6 units Lot/code info: GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.

UPC codes

00810087180126

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.