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Intra-Aortic Balloon Pump Recall

In March 2014, Maquet Datascope Corporation, a division of the Sweden-based Getinge Group, recalled approximately 12,300 of its intra-aortic balloon pumps (IABP) on a worldwide basis. The recall affects devices from various models produced over more than an eight-year period and distributed during this same timeframe.

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Maquet IABP Problems

Intra-aortic balloon pumps are electromechanical devices that provide support to the left heart ventricle using counterpulsation in temporary or emergency situations. An IABP system needs to run continuously to help pump blood, and if stopped for too long it may cause problems for the patient that can lead to complications and possibly even death.

Based on customer complaints, Maquet determined that the power supplies and fans on a range of their products were not working as designed. Specifically, a fan retaining ring was shaped incorrectly in some models, and under certain conditions the ring could separate from rest of the assembly and cause the fan to stop operating properly. Upon failure of the fan, IABP power supplies are liable to shut down without warning, potentially reducing blood flow to patients and putting them in harmful and life-threatening situations. After conducting an internal investigation, in which the company found at least 106 reports of failure tied to their IABP systems, Maquet Datascope Corporation decided to recall affected models worldwide. 1

Intra-Aortic Balloon Pump Models Recalled

Models affected by the recall were manufactured from January 1, 2003, through June 30, 2011, and distributed during basically the same period. The following models were listed in the recall notice:

  • System 98/98XT
  • CS100/CS100i
  • CS300

The FDA has stated that IABP models listed in the recall can continue to be used until replacements or repairs can be made. However, the agency urges health professionals and patients to be aware that the pumps could fail without any advance notice. In addition, the FDA suggests that substitute backup pumps should be made available in the event of a failure. 2

FDA Involvement with Maquet IABP Devices

In a March 2014 safety communication, the U.S. Food and Drug Administration warned the public about the Maquet intra-aortic balloon pump recall. In the same communication, the agency classified the measure as a Class 1 recall, the most serious recall category, reserved for products that have a “reasonable probability” of causing “serious adverse health consequences or death.”

Despite the serious nature of the recall, the FDA has not at this time banned IABP devices. As of the date of the communication, there were no reported patient injuries or deaths related to the power supply malfunction. 3

  1. Maquet Datascope Corporation. “Supplement to March 21, 2014 Recall Notice.” (July 7, 2014). Accessed Oct. 2, 2014.
  2. Maquet Datascope Corporation. “Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps For Potential Mechanical Failure of the Power Supply Fan Assembly.” (May 9, 2014). FDA.gov. Accessed Oct. 2, 2014
  3. Food & Drug Administration. “Maquet Datascope Corporation, Intra-Aortic Balloon Pumps, System 98/98XT, CS100/CS100i, and CS300 – Potential Failure of Fan Assembly May Cause Pumps to Shut Down Without Any Alarm.” (March 21, 2014). FDA.gov. Accessed Sept. 26, 2014.