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.
Reported: January 16, 2013 Initiated: March 27, 2012 #Z-0662-2013
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 29 units (total)
- Distribution
- 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
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Maquet Cardiovascular, LLC. Units affected: 29 units (total).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 16, 2013. Severity: Moderate. Recall number: Z-0662-2013.
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