The FDA announced a broad recall of cardiac balloons manufactured by Edwards Lifesciences. The formal name of the recalled product is IntraClude Intra-Aortic Occlusion Device ICF100. Most people not in the healthcare industry call these devices a balloon.
The FDA claims there may be three deaths linked to defective balloons. Although only 757 of these balloons have been recalled, 22 have already failed, a huge percentage. In fact the failure rate is so high that the FDA gave this recall its highest priority.
According to regulators, the following devices have been recalled:
Model: IntraClude Intra-Aortic Occlusion Device ICF100 Model: ICF100
UDI code (01) 00690103190007
Lots:
60972890 61078031 61097633 61139239 61259627 61259628 61713218 61723505 61898939
Distribution Dates: May 1, 2017 to February 19, 2019
Devices Recalled in the U.S.: 757
The FDA says, "The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death."
According to the manufacturer's literature, Edwards Lifesciences cardiac balloons are "indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated." We will translate that into English in a minute.
This isn't the first time the company had problems with these devices. Just one year ago the company notified physicians that the device could leak. Here is what they said then:
Description of the Problem
Edwards Lifesciences has identified a potential safety risk, which may occur during the use of the
IntraClude intra-aortic occlusion device (ICF100). Edwards Lifesciences has received a limited
number of reports regarding inflation fluid leaking out the distal open end of the strain relief. When
present, this leak can be identified through normal monitoring of balloon pressure, and it causes
the medical staff to continue adding inflation fluid to the balloon, typically about 2-5 ml every 10-
15 minutes for up to 50 ml total, to maintain balloon pressure sufficient for adequate occlusion of
the ascending aorta.
Potential Hazard
If the leak exists, the IntraClude balloon may not provide an adequate occlusion of the ascending
aorta. Device replacement or external aortic cross-clamping may be required if balloon occlusion
cannot be maintained and the procedure may need to convert to an open procedure. No reports
of illness or injury have been reported in any of the complaints relating to this issue.
Now we know the problem is much more severe. In fact, there is a risk that the balloon could burst causing a stroke, neurological damage or death.
Edwards Lifescience Cardiac Balloons - for the Non Healthcare Professional
We understand these recall notices are difficult to understand. They are written for physicians and healthcare workers, not patients.
In layman's terms, doctors use an IntraClude balloon to block the aorta during surgery. The aorta is the large artery that carries oxygenated blood from the heart to the rest of the body. The Edwards Lifesciences device temporarily assists with a machine that functions as a mechanical heart. The inflated balloon isolates the heart during the procedure.
Because the balloon is so critical, should it fail the results could be fatal. When the balloon fails, the heart fills with blood. Doctors must immediately find another device or resort to open heart surgery.
When a balloon fails, the patient is invariably on an artificial heart for a longer time raising the risk of stroke, permanent damage or an embolism.
Injured or Killed Because of a Defective Cardiac Balloon?
Thankfully there are only 757 of these bad devices in circulation and many have been identified and recalled. With 22 failures, the statistical significance is staggering.
Edwards Lifesciences claims they still don't know why these devices are failing. That doesn't make them any less responsible for any deaths or injuries, however.
If you were injured by a defective Edwards Lifesciences Cardiac Balloon, you may be entitled to significant compensation. The same is true if you lost a loved one during one of these procedures.
Although the oldest recalled device was made in May of 2017, some states give patients a very short window to file a lawsuit for damages. Those damages can include past and future lost earnings, medical bills, future medical bills, therapy bills, future medical bills and pain and suffering and emotional anguish. If you think you have a claim, don't wait.
We understand that the injuries from a cardiac surgery gone wrong can be catastrophic. These injuries are not only physically severe, they frequently take a huge toll on one's emotional and financial stress. If you or a loved one suffered a needless injury because of defective Edwards Lifesciences cardiac balloons, we may be able to help. Contact is today for a no obligation, no fee review of your case.
For more information, contact us online, by email at [hidden email] or by phone at 800.669.7782. Cases accepted nationwide. We also invite you to visit our defective products information page.
Special Notice for Employees of Edwards Lifesciences and Other Device Manufacturers
We don't why Edwards Lifesciences didn't recall these devices in the spring of 2018. They certainly knew something was wrong. By waiting up to 22 people - and maybe more -died or suffered. Why?
If you are aware of defective products and know the company is hiding information about the defects, you may be entitled to a reward. Even if no reward is available, your quick actions can save lives. We proudly represent whistleblowers and help them receive the maximum rewards possible. Contact us, all inquiries are kept strictly confidential and your call is protected by the attorney - client privilege.