Abiomed Impella Heart Pump Lawsuit

Abiomed Impella Heart Pumps were recalled after at least 49 people died when a doctor accidentally punctured their heart while implanting the device.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Abiomed Impella Heart Pump induced injury cases in all 50 states. If you or somebody you know was injured or died from problems with a heart pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Abiomed Impella Heart Pumps Recalled After 49 Deaths

The FDA announced its highest-level Class 1 recall for Abiomed Impella Heart Pumps after at least 129 people were seriously injured, including 49 people who died, when doctors punctured the heart while inserting the device.

What is the Risk?

Pump catheter may perforate (cut) the wall of the left ventricle
Broken blades entering the patient’s bloodstream
Heart perforation
Organ damage
Heart pump impeller blade fracture
Pump stops working and blood circulation stops
Loss of blood flow
Internal bleeding
Brain damage
Blood clots
Particle deposits forming
Fluid leaks from pump
Death

What is the Problem?

Abiomed recalled about 66,000 Impella Left Sided Blood Pumps because the pump catheter can cut through the wall of the left ventricle of the heart during operations to implant the device, which can cause catastrophic bleeding and death. According to the FDA:

“The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”

What Are Impella Heart Pumps?

The Impella Left Sided Blood Pump is a medical device that is used to temporarily help the heart pump blood to the body. It is manufactured by Abiomed, a part of Johnson & Johnson MedTech.

How Does It Work?

The Impella device looks like a straw. A doctor inserts the device through the major blood vessels of the patient’s heart into the left ventricle, which is the main pumping chamber of the heart. The Impella device helps move blood out of the heart and into the body.

What Patients Need Heart Pumps?

Patients may be implanted with the Impella Left Sided Blood Pump when their heart is unable to pump enough blood to the body due to a heart attack, open heart surgery, or when the heart is not working well due to a condition called cardiomyopathy.

What Does It Do?

The Impella Left Sided Blood Pump reduces the work-load on the heart and provides support for the circulatory system so the heart has time to recover and heal. There are several types of Impella pumps that are used for different therapeutic purposes.

How To Identify Recalled Heart Pumps

The recall includes about 66,390 Impella heart pumps that were distributed in the U.S. between October 2021 and October 2023. The recall involves the following heart pumps:

Impella 2.5
Impella CP
Impella CP with SmartAssist
Impella 5.0
Impella 5.5 with SmartAssist
Impella LD

Abiomed Warns Patients About Heart Perforation Risk

Abiomed first warned physicians about the risk of heart perforations in a Technical Bulletin issued in October 2021. However, this warning was not shared with the FDA.

In September 2023, the FDA inspected Abiomed and sent the company a warning letter for failing to disclose reports of injuries and deaths from heart perforations.

In December 2023, Abiomed sent an Urgent Medical Device Correction letter to all affected customers, urging physicians to adhere to these new and revised warnings:

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

June 2023: Impella Heart Pumps Recalled After 4 Deaths

In June 2023, about 7,895 Abiomed Impella Left Sided Blood Pumps were recalled due to a risk of motor damage, which could cause sharp pieces of broken blades to enter the patient’s bloodstream, or cause other life-threatening injuries. There were 26 injuries and 4 deaths reported at the time of the recall.

The risk of motor damage occurs when when the Impella heart pump comes in contact with Transcatheter Aortic Valve Replacement (TAVR) Stents, which are implanted in certain patients.

Contact between an Impella heart pump and a TAVR stent can damage or destroy the Impella motor’s impeller blades. According to the recall:

“There is also a risk that pieces of the broken blades could enter the patient’s bloodstream. … The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient.”

Abiomed Recalls Impella 5.5 with SmartAssist for Purge Fluid Leaks After 3 Injuries

In April 2023, Abiomed recalled certain Impella 5.5 with SmartAssist Heart Pumps after customers complained about purge fluid leaking from the purge sidearm of the pump. There were 179 complaints and 3 injuries reported.

According to the recall: “If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death.”

Abiomed Recalls Impella RP Flex With SmartAssist After 12 Injuries

On June 29, 2023, Abiomed recalled Impella RP Flex with SmartAssist Heart Pumps due to a risk of serious injuries, including blood clots, particle deposits forming, or death. There were 12 reported injuries at the time of the recall.

The problem was that the catheters’ Instructions for Use (IFU) do not appropriately address precautions for health care providers to take when treating patients whose anticoagulation clotting time is below the recommended value, according to the recall.

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