Biosense Webster, Inc. recalls PENTARAY NAV High-Density Mapping Catheter.

Recall date

May 17, 2017

Source

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

Recall number

Z-0212-2018

FDA classification

Class II

Brand / firm

Biosense Webster, Inc.

Sold / distributed

Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan…

Why it was recalled

Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

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

What was recalled

PENTARAY NAV High-Density Mapping Catheter.