Boston Scientific Corp recalls IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM962…

Recall date

February 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1209-2015

FDA classification

Class I

Brand / firm

Boston Scientific Corp

Sold / distributed

Distributed in Germany, Great Britain, and the Netherlands.

Why it was recalled

Reports of formation of char adherent to the proximal part of the distal tip electrodes

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.