Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product(s):
- Datascope Corp./MAQUET Intra-Aortic Balloon Pump
- Model/Item Numbers: CS100i, CSO100, CS300
- Lot Numbers: All Lots Manufactured July 1, 2003 to June 16, 2017
- Manufacturing Dates: July 1, 2003 to June 16, 2017
- Distribution Dates: March 24, 2003 to June 16, 2017
- Devices Recalled in the U.S.: 5,049
Device Use
Datascope Corp./MAQUET’s CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps (IABP) 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.
Reason for Recall
Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. 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.
Who May be Affected
- Hospitals and health care professionals using a Datascope Corp./MAQUET Intra-Aortic Balloon Pump that was manufactured July 1, 2003 to June 16, 2017 and has not been serviced and upgraded by the manufacturer.
- Patients receiving circulatory support with a Datascope Corp./MAQUET Intra-Aortic Balloon Pump that was manufactured July 1, 2003 to June 16, 2017.