MAQUET Intra-Aortic Balloon PumpMaquet Datascope Corp. has issued several recalls for Intra-Aortic Balloon Pumps (IAPBs) because the device can shut down without warning, resulting in severe patient injuries or death.

Need a Texas Datascope Intra-Aortic Balloon Pump Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured, needed to be resuscitated, or died from an IAPB that failed, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

Class I Recall for Cardiosave® Intra-Aortic Balloon Pump

In May 2018, Maquet Datascope Corp. recalled over 2,800 of the CARDIOSAVE® Hybrid Inta-Aortic Balloon Pumps (IABP) because a design flaw can allow fluid (such as saline) to seep into the device.

This can result in corrosion, short-circuiting, power failure, and device shut-down resulting in a patients suffering severe injury or death, according to the FDA:

“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.”

Datascope Recalls CS100i Intra-Aortic Balloon Pump

In June 2017, Datascope/MAQUET recalled approximately 12,319 units of the CS 100i Intra-Aortic Balloon Pumps (IABPs). The FDA expanded the recall to include all CS 100i, CSO100, and CS30 IABPs that were manufactured before June 30, 2013.

What is the problem?

The FDA warns that an electrical failure may cause a “false blood-detection alarm and ingress of fluid” into the pump. According to the Class 1 recall notice, “device failure may result in immediate and serious adverse health consequences, including death.”

One patient death was reported by the manufacturer:

“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.”

Recalled Product Information

  • 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

What is an IABP?

Intra-Aortic Balloon Pumps (IABPs) are mechanical devices that use a balloon to help the heart circulate blood. IAPBs are implanted in the aorta of patients who are undergoing cardiac and non-cardiac surgery, as well as patients who have had a severe heart attack or complications of heart failure.

Need an Intra-Aortic Balloon Pump Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.

Meet Your Attorney

Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

To contact Collen, please fill out the contact form below:

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 879-3040.
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