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Datascope Intra-Aortic Balloon Pump Lawsuit

Intra-aortic balloon pumps have been recalled over alleged defects that could cause failure of the devices, adverse health complications, and death. At least one patient death due to failure of the balloon pump to initiate therapy has been reported.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

No-Cost Confidential Case Review: Should you or someone close to you have experienced adverse health effects following the use of a Datascope Intra-Aortic Balloon Pump, it is imperative that you immediately get in touch with our legal team for a complimentary consultation. You could qualify for financial restitution through a lawsuit, and our litigators are equipped to assist you.

What’s the Problem with Aortic Balloon Pumps for Non-Cardiac Surgery?

Datascope Corp./MAQUET is recalling 5,049 balloon pumps over alleged defects that could cause failure of the devices, resulting in adverse health complications, including death.

Datascope Models affected by the field correction action include CS100i, CS100, and CS300, which were manufactured from July 1, 2003 to June 16, 2017.

According to the FDA Safety Alert, the recall also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP. [1]

Datascope Balloon Pumps are cardiac devices used to assist cardiac surgery patients and to treat patients with acute coronary syndrome (ACS) or complications from heart failure.

The recall was issued over concerns that if a patient requires circulatory support with an intra-aortic balloon pump and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.

At least one patient death due to a false blood detection alarm has been reported. Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could fail to initiate therapy.

Getinge/Maquet said it was developing new software to address the issue around February 2019.

However, that does not take away from the potential for injury to patients; or the harm to families of patients who may have died from cardiovascular complications the device was responsible for.

Related article: Intra-Aortic Balloon Pump Catheter Recall Lawsuit

FDA Expands Class I Recall and Statistics

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 2003 to December 11, 2013.

Around 12,000 units globally were affected, distributed between March 23, 2003, and December 11, 2013.

The issue led to a patient’s death due to a device failing to initiate therapy, identified as electrical test failure code #58. Units distributed after December 11, 2013, are not affected. The recall includes replacing defective solenoid driver boards​

Intra Aortic Balloon Pump

How Do IABPs Work for Patients Undergoing Cardiac Surgery?

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.

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Have you or a loved one suffered severe pain or injury from a defective medical device?

Cardiosave Intra-Aortic Balloon Pump Recall

In May 2018, the U.S. Food and Drug Administration issued a recall for nearly 3,000 CARDIOSAVE hybrid IABPs manufactured by Maquet Datascope Corp.

The problem is that a design flaw could allow fluid (such as saline) to get inside the aortic balloon pump. 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 – the FDA said. Device failure may result in immediate and serious adverse health consequences, including death

Contact us today to speak to experienced defective medical device attorneys to learn more about your legal rights.

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Get a Free Datascope Intra-Aortic Balloon Pump Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at our law firm Schmidt & Clark, LLP is an experienced team of trial lawyers that focus on the representation of plaintiffs in Datascope Intra-Aortic Balloon Pump Lawsuits. Our law firm is handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Case Evaluation: Again, if you or a loved one is injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Reference:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/datascope-corpmaquet-issues-worldwide-voluntary-recall-system-cs100-cs100i-and-cs300-intra-aortic

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