Cordis SABER PTA Balloon Dilation Catheter recalled over foreign material

Recall date

July 19, 2021

Source

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

Official notice title

Cordis Corporation recalls Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Recall number

Z-2235-2021

FDA classification

Class II

Brand / firm

Cordis Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.

Why it was recalled

The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

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

What was recalled

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X