FDA Class 1 Recall for Datascope/MAQUET’s Intra-Aortic Balloon Pump

The U.S. FDA has deemed as a Class 1 recall the Datascope Corporation/MAQUET voluntary worldwide field correction, issued in March  of certain of the company’s Intra-Aortic Balloon Pumps (IABPs).

 

Background

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. The problem that has provoked this action lies in a potential mechanical failure of the fan assembly associated with the power supply. Needless to say, the consequences of this failure are quite serious: 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.

Hence the FDA’s Class 1 recall which the agency defines as as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Having said which, to date, there have been no reported patient injuries or deaths related to the power supply malfunction. 

The corrective action associated with this recall is to provide a replacement fan assembly to all IABPs containing an affected fan assembly. A MAQUET Service Representative will contact those facilities with affected IABP’s to schedule corrective action and document this corrective action during a visit to the customer.

The company says 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.

There are approximately 12,360 affected units sold globally and all customers that may have an intra-aortic balloon pump affected by this field correction have been notified.

Source: MAQUET, PR Newswire

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