LeMaitre Vascular, Inc. recalls The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon si…

Recall date

July 24, 2019

Source

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

Recall number

Z-2448-2019

FDA classification

Class II

Brand / firm

LeMaitre Vascular, Inc.

Sold / distributed

GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK

Why it was recalled

incorrect device size being listed on the impacted device packaging

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

What was recalled

The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.