Class I Recall Issued for Datascope Intra-Aortic Balloon Pumps

Washington, DC: Datascope Corp./MAQUET is recalling 5,049 defective CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps made from July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump.

Datascope Corp./MAQUET's CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.

The recall was issued because if a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.

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Published on Sep-6-17