What Is the Abiomed Impella Heart Pump?

Abiomed, a subsidiary of Johnson & Johnson, introduced the Impella Heart Pump in 2008. Advertised as the world’s smallest heart pump, it allows the heart to rest and recover as it takes over the pumping function to deliver blood and oxygen to the rest of the body. 

The device is typically used during high-risk catheter operations called percutaneous coronary interventions (PCI). Someone may also receive the Abiomed Impella Heart Pump when:

• There is an ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack. 
• The heart is not functioning properly due to cardiomyopathy. 
• The patient receives open-heart surgery. 

The pump is designed to reduce the work done by the ventricles so the heart can recover.  

Understanding Impella Heart Pump Risks

The recall and subsequent lawsuits have identified several factors that account for the Impella Heart Pump failure. One of the primary malfunctions linked to the Abiomed Impella Heart Pump is the risk of perforation.  

During operations, the pump catheter may cut the wall of the heart’s left ventricle. An Impella Heart Pump perforation could result in the patient suffering free wall rupture, hypertension, lack of blood flow, or death. 

Another major issue with the pump is damage to the device’s blades or motor during transcatheter aortic valve replacement (TAVR). The motor’s spinning blades could be destroyed if the pump’s motor housing touches the stent of a TAVR. If the pump’s blades are not properly functioning, this can reduce blood flow, or the device may stop pumping altogether.

Moreover, the broken blade pieces may enter the patient’s bloodstream, requiring immediate surgical intervention. 

An Abiomed Impella Heart Pump perforation or other complication may lead to heart failure, brain damage, or death. 

About the Impella Heart Pump Recall

On June 14, 2023, Abiomed recalled all Impella Left Sided Blood Pumps over the risk of motor damage after contact with the TAVR stent. The recall impacted 7,895 devices in the U.S. 

Then, the company launched another recall on December 27, 2023. However, this recall did not apply to the devices but instead to their instructions. Abiomed sent an Urgent Medical Device Correction letter to affected customers, which included new and revised warnings: 

• Carefully situate the pump during operations. 
• Use advanced imaging when moving the pump.
• Exercise special care when inserting the pump. 

The instruction recall affected 66,390 devices distributed between October 2021 and October 2023. The recalls affected the following Impella Heart Pump products: 

• Impella 2.5 Blood Pump
• Impella 5.0 Blood Pump
• Impella 5.5 with Smart Assist Blood Pump
• Impella CP Blood Pump
• Impella CP with SmartAssist Blood Pump
• Impella LD Blood Pump

Unfortunately, there have been 129 reported serious injuries, including 49 reported deaths. 

The FDA labeled both events as Class I recalls, their most serious type of recall. The agency reserves this classification for devices that can cause serious injury or death. 

We recognize how frightening and frustrating it is for patients to receive a defective medical device. Determining whether your implant was part of a recall can be confusing. 

The team of Impella Heart Pump injury lawyers at Osborne & Francis can identify if you qualify for legal action. We encourage you to reach out online or call (561) 293-2600 if you have any questions about your potential claim.