Datascope Corp/MAQUET initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT,CS100/CS100i and CS300 IABP brand names for a potential mechanical failure of the fan assembly associated with the power supply. There were approximately 12,360 affected units sold globally.
The intra-aortic balloon pump is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle via the principle of counterpulsation. Counterpulsation is a technique for assisting the circulation and decreasing the work of the heart, by synchronizing the force of an external pumping device with cardiac systole and diastole.
As a result of customer complaints related to a malfunction of the System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps (IABP), Datascope Corp/MAQUET conducted an investigation and identified a potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. An IABP shutdown could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
Between January 1, 2003 and June 30, 2011, specific System 98/98XT, CS100/CS100i and CS300 IABPs were manufactured with the affected fan assembly, or may have received an affected fan assembly during an upgrade/service of the IABP in the field. The affected IABP units were distributed in the US and worldwide (in over 100 countries). The affected IABPs can be identified by part and serial number.
The affected System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps involved in the field correction can be used while waiting for parts and service. Customers should adhere to the instructions for use when using an affected intra-aortic balloon pump.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Recall Announcement
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues