Datascope Corp./MAQUET is recalling some of its Intra-Aortic Balloon Pumps (IABP) because a defect with the cardiac assist devices’ false detection alarm sends an ingress of fluid into the Intra-Aortic Balloon Pump. If a patient requires circulatory support with 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.
IABPs are used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
Affected Datascope Corp./MAQUET IABP devices have the model numbers CS100i, CS100, and CS300 and include those manufactured July 1, 2003, to June 16, 2017, that have not been serviced and upgraded by the manufacturer.
Datascope Corp./MAQUET sent customers with affected devices an “Urgent Product Recall Medical Device Field Correction” letter informing them of the device’s risks, and listing actions that should be taken to minimize patient harm until affected IABP units can be serviced.
Any quality issues with these devices or adverse events related to this defect should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice