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

Hazard

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Details from the source

Reason for recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. Distribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland. Quantity: 18 units Lot/code info: GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.

UPC codes

00810087180126

Source

Official record: FDA (Device enforcement) ↗

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