FDA-Device2013-01-16Class II
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
Maquet Cardiovascular, LLC
Hazard
In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
Sold states
Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand
Affected count
29 units (total)
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0662-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief