FDA-Device2019-09-11Class II
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.
LeMaitre Vascular, Inc.
Hazard
incorrect device size being listed on the impacted device packaging
Sold states
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Affected count
62 units
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2019Don't want to check this manually?
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