Cordis Corporation recalls RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertens…

Recall date

April 15, 2014

Source

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

Recall number

Z-2405-2015

FDA classification

Class II

Brand / firm

Cordis Corporation

Sold / distributed

Distributed in Germany only.

Why it was recalled

Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.

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

What was recalled

RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.