Maquet Datascope Corp. has recalled several types of Intra-Aortic Balloon Pumps (IABP) due to battery problems, sudden shut-downs, and patients who died or needed to be resuscitated when the device failed without warning.
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 was injured, needed to be resuscitated, or died, 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.
Class I Recall for Cardiosave® Intra-Aortic Balloon Pump
In May 2018, a recall was issued for over 2,800 CARDIOSAVE® Hybrid Inta-Aortic Balloon Pumps (IABP) manufactured by Maquet Datascope Corp.
The problem is that a design flaw could allow fluid (such as saline) to get inside the device. The fluid can cause corrosion, short-circuiting, power failure, and device shut-down. Patients may need to be resuscitated, or suffer severe injury or death:
“The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.”
CS100 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 was injured, needed to be resuscitated, or died, 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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