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Boston Scientific Corp recalls IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM962
Recalled March 11, 2015 · FDA recall Z-1209-2015 · Boston Scientific
Hazard
Reports of formation of char adherent to the proximal part of the distal tip electrodes · FDA Class I
Units
14 units
Sold at
Distributed in Germany, Great Britain, and the Netherlands.
Description
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Product
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.
Manufacturer(s)
Boston Scientific Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →