On September 20, 2018, the U.S. Food and Drug Administration announced a worldwide recall of Getinge/Maquet MAQUET Cardiosave Intra-Aortic Balloon Pumps (IABP) for complications during high altitudes.
What is an IABP?
An IABP is used in patients undergoing cardiac or non-cardiac surgery, as well as those with coronary syndrome or complications from heart failure. It may also be used to treat arrhythmias or heart infections.
An IABP is used with the Intra-Aortic Balloon (IAB). The IAB is a skinny “balloon” that controls blood flow through the aorta, the largest blood vessel in the body.
When the heart pumps from assistance with the IAPB, the device gets smaller to allow for blood flow to the body. When the heart relaxes, it helps keep blood in the heart. An IABP is power operated and must be at all times.
IABP Device Failure
The problem is the device may fail during battery operation during high altitudes, leading to unstable blood flow in the body. According to the press release, “This condition could potentially lead to patient hemodynamic instability.”
Another press release on the Getinge/Maquet website states, “The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.”
So far there has been one death reported in association with the device shutting off and failing to operate with sufficient power due to its driver board.
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.
The following IAPB Cardiosave devices affected were distributed between March 06, 2012 and August 31, 2018:
Cardiosave Hybrid IAPB
0998-00-0800-XX
Cardiosave Rescue IABP
0998-UC-0800-XX
Patients with the following balloon name and size were warned to take certain altitude precautions:
Balloon Name and Size:
Sensation 34cc / 40cc
Sensation Plus 40cc / 50cc
Operating Altitude:
-1,250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)
-381 to 975 meters (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)
Balloon Name and Size:
Mega 50cc
Operating Altitude:
-1,250 feet to 5,000 feet (795 mmHg to 632 mmHg) (1,060 hPa to 843hPa)
-381 to 1,524 meters (795 mmHg to 632 mmHg) (1,060 hPa to 843 hPa)
Balloon Name and Size:
Mega 30cc / 40cc
Linear 25cc / 34cc / 40cc
Operating Altitude:
-1,250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa)
-381 to 3,657 meters (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa)
Questions About a Getinge/Maquet IABP Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or a loved one have suffered injuries from a Getinge/Maquet IABP model, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new Getinge/Maquet IABP lawsuits across the country, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
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