The FDA issued a Class I recall on an intra-aortic balloon pump due to a potential defect that may make it stop functioning. The pump provides temporary emergency support for cardiac events such as an MI or severe heart failure, or before heart surgery.
Maquet informed its customers that some intra-aortic balloon pumps may have a misshapen retaining ring that could separate within the fan assembly. If that happens, the fan may stop rotating, overheating the power supply, which may shut down the pump. The resulting decrease flow of blood might lead to clotting and circulatory problems that long term could contribute to organ injury, tissue damage or death.
The voluntary recall involves the pumps sold under the Datascope Corp. System 98/98XT (Part Numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 (Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx). They were manufactured between Jan. 1, 2003, and June 30, 2011, and distributed from Jan. 17, 2003, through June 30, 2011.
Maquet reported that about 12,360 affected products have been sold globally and affected customers have been notified. Hospitals and physicians waiting for a replacement pump or a repair can continue to use a recalled pump, but they should have a backup available. If the pump stops and a substitute pump is not available, they should remove the balloon immediately.