Terumo Medical Corporation recalls Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human…

Recall date

November 6, 2015

Source

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

Recall number

Z-2033-2017

FDA classification

Class II

Brand / firm

Terumo Medical Corporation

Sold / distributed

Nationwide Distribution.

Why it was recalled

Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.

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

What was recalled

Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.