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LeMaitre Vascular, Inc. recalls The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon siz
Recalled September 11, 2019 · FDA recall Z-2448-2019 · LeMaitre Vascular
Hazard
incorrect device size being listed on the impacted device packaging · FDA Class II
Units
62 units
Sold at
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Description
incorrect device size being listed on the impacted device packaging
Product
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.
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →