Biosense Webster, Inc. recalls WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation a…

Recall date

April 17, 2015

Source

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

Recall number

Z-1525-2015

FDA classification

Class II

Brand / firm

Biosense Webster, Inc.

Sold / distributed

US nationwide distribution.

Why it was recalled

The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

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

What was recalled

WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413