FDA: Maquet/Datascope recalls certain Intra-Aortic Balloon Pumps

Editor's Note

The Food and Drug Administration (FDA) on June 19 announced the recall by Maquet/Datascope (Fairfield, New Jersey) of its System CS100, CS100i, and CS300 Intra-Aortic Balloon Pumps. The recall also applies to System 98 or System 98XT IABP that was converted to a CS100i or CS 300 IABP.

The recall was initiated because of a potential electrical test failure code. The company received a complaint that has been associated with a patient death because the device failed to initiate therapy.

Affected units were distributed between March 23, 2003 and December 11, 2013.

Posted 06/19/2017] AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code. This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.