Terumo Medical Corp recalls MISAGO RX Self Expanding Peripheral Stem

Recall date

August 4, 2016

Source

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

Recall number

Z-0669-2017

FDA classification

Class II

Brand / firm

Terumo Medical Corp

Sold / distributed

Nationwide

Why it was recalled

During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

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

What was recalled

MISAGO RX Self Expanding Peripheral Stem