Boston Scientific Corporation recalls Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog…

Recall date

October 24, 2019

Source

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

Recall number

Z-0578-2020

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Why it was recalled

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.