FDA Warns Heart Device Connected to Deaths and Injuries

Recently, the Food and Drug Administration (FDA) issued a serious warning over the use of Abiomed’s left-sided Impella heart pumps, which can perforate the heart and have already been implicated in 49 deaths and more than 100 injuries. Although the FDA is not mandating a product recall, it has put forth what is known as a Class I recall. The agency only issues Class I recalls, which are the most serious type, when use of a device may cause significant injury or death.

What is the Impella Left-Sided Blood Pump?

According to the FDA, Impella left-sided blood pumps are used for “short term support of the pumping chambers of the heart (ventricles) during high-risk-catheter-based procedures” in addition to being used in cases where there a patient is suffering from ongoing cardiogenic shock (that occurs less than 48 hours after a serious heart attack), has undergone open-heart surgery, or when the heart is functioning poorly as a result of cardiomyopathy. When appropriate, the Impella left-sided blood pump is used to take some of the pressure off the heart’s ventricles by providing support to the circulatory system. This gives the heart time to heal.

Complications Associated with Abiomed’s Heart Pumps

So far, the FDA has received at least 129 reports of Abiomed’s left-sided heart pumps causing serious injury in patients, including reports of 49 deaths. Abiomed is complying with the FDA’s recall, which details how the device’s pump catheter may perforate or cut the wall of the heart’s left ventricle during an operation. If this happens, it can lead to significant and dangerous medical complications like hypertension, lack of blood flow, left ventricle perforation or free wall rupture, and death. The FDA reports that people who may be affected by the recall include individuals who are undergoing a procedure with Abiomed’s left-sided blood pump, people with anterior infarction (heart disease), the elderly, and women.

The FDA’s Use Warning

Although the FDA issued a Class I recall, the agency is not actually pulling the left-sided blood pump from the shelves. Instead, the FDA is requesting that customers, i.e. medical professionals, observe the following new and revised device warnings:

• Carefully position the pump catheter during any operative procedure
• Use imaging when advancing or torquing the pump catheter
• Exercise special care when inserting the pump catheter in patients with certain high risk conditions or during active CPR
• Review the FDA’s updated warnings in the device’s Instructions for Use
• Notify everyone at your facility who needs to be aware of this recall correction
• Notify all other facilities where the products have been forwarded of the updated Instructions for Use

In addition to following the FDA’s new and revised device warnings, the agency also requests that customers or recipients of the Impella left-sided heart pump who observe or experience adverse effects or quality issues report them here.

Although it is complying with the FDA’s recent correction, the manufacturer actually first disclosed the issue in a technical bulletin back in 2021. However, the manufacturer did not inform the FDA about the bulletin, therefore violating the agency’s protocols that are in place to protect people from preventable, adverse reactions linked to dangerous or defective devices. Another major issue is whether the device is even safe to use with the FDA’s updated recommendations, which certain consumer safety groups fear is not.

Recovering Damages for Your Injuries

Individuals who are harmed by faulty, unreasonably dangerous or defective medical devices may be able to recover damages for their injuries by filing a products liability or medical malpractice claim against the negligent party or parties. Because medical device and malpractice claims are time-consuming and complex, it is good to have an experienced team of attorneys on your side. At Galfand Berger, our lawyers have been fighting on behalf of injured victims for decades. If you would like to learn more about filing a claim, please contact a representative online now who can help.

Philadelphia Medical Malpractice Lawyers at Galfand Berger, LLP, Representing Injured Victims Since 1947

If you have questions about filing a claim for injuries you sustained, contact the Philadelphia medical malpractice attorneys at Galfand Berger LLP today. Call us at 800-222-USWA (8792) or fill out our online form for a free consultation. Located in Philadelphia, Bethlehem, Lancaster, and Reading, we serve clients throughout New Jersey and Pennsylvania, including Allentown and Harrisburg.