Hansen Medical Inc recalls Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

Recall date

March 18, 2015

Source

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

Recall number

Z-1449-2015

FDA classification

Class II

Brand / firm

Hansen Medical Inc

Sold / distributed

Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.

Why it was recalled

Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.

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

What was recalled

Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.