LeMaitre Vascular, Inc. recalls The LeMaitre Aortic Occlusion Catheter is a single lumen cat
Recalled 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.
Hazard / Issue
incorrect device size being listed on the impacted device packaging
Issued by
FDA
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