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Datascope Intra-Aortic Balloon Pump Lawsuit

Datascope Intra-Aortic Balloon Pump Lawsuit

 Intra-Aortic Balloon Pumps (IABPs) were recalled by Datascope Corp./MAQUET because an electrical problem may cause the balloon to fail to circulate blood. One patient death is blamed on the problem.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting intra-aortic balloon pump induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Intra-Aortic Balloon Pump Recall

In June 2017, Datascope Corp./MAQUET issued a worldwide recall for about 12,319 units of the CS 100i, CSO100, and CS300 Intra-Aortic Balloon Pump. The recall involves the following products:

  • Datascope Corp./MAQUET Intra-Aortic Balloon Pump
  • Model/Item Numbers: CS100i, CSO100, CS300
  • Lot Numbers: All Lots Manufactured Before June 30, 2013
  • Manufacturing Dates: July 22, 2003 to June 30, 2013
  • Distribution Dates: March 24, 2003 to December 11, 2013
  • Devices Recalled in the U.S.: 9,194

FDA Expands Class 1 Recall

The FDA expanded the recall and designated it as “Class 1,” which is the highest level of recall the agency can issue. The expanded recall involves all lots manufactured before June 30, 2013, including units distributed in the U.S. from March 24, 2003 to December 11, 2013.

What is the problem?

The FDA said the problem is a “false blood-detection alarm and ingress of fluid” into the pump. Datascope/MAQUET implemented a design change in June 2013 to address the problem, but the FDA said not all devices made before then were serviced or upgraded.

“The device failed to pump due to an electrical test failure … which has been associated to a patient death due to the failure of the device to initiate therapy.”

What is an IABP?

Intra-Aortic Balloon Pumps (IABPs) are mechanical devices that help the heart pump blood. The devices use a balloon that inflates and deflates in time with heartbeats. IABPs are used in patients undergoing cardiac and non-cardiac surgery, as well as patients who have had a severe heart attack or heart failure.

Do I have an Intra-Aortic Balloon Pump Lawsuit?

The Schmidt Firm, PLLC is currently accepting intra-aortic balloon pump induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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