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.
What Type of Compensation Is Available if My Impella Heart Pump Is Defective?
It is important to remember that every case is different. Although the type and amount of compensation available to individuals who suffered an Impella Heart Pump injury may vary from case to case, you may be able to recover:
- Past and Future Medical Expenses: A lawsuit can reimburse patients for open heart surgery, hospital stays, doctor's appointments, medication, hospital bills, therapy, and more.
- Lost Wages or Loss of Future Earning Capacity: Compensation may cover wages lost while the patient is recovering or apply to future income if they are too ill to work.
- Pain and Suffering: The physical pain and mental anguish that accompany a defective heart pump can be excruciating. A claim can help patients collect compensation for the emotional distress and bodily harm they have endured.
- Wrongful Death Costs: The Abiomed Impella Heart Pump has already cost dozens of patients their lives. If your family is grieving the loss of a loved one from this device, then wrongful death compensation can go toward funeral expenses, loss of financial support from the deceased victim, and other financial hardships.
Who Is Eligible for an Abiomed Impella Heart Pump Lawsuit?
If an Abiomed Impella Heart Pump injured you or contributed to the death of a family member, then you may be eligible to pursue financial compensation. When considering filing a lawsuit, you must be able to show that:
- A medical professional used a heart pump when operating on the patient for cardiac arrest or cardiogenic shock.
- The patient underwent valve replacement surgery, during which the heart pump failed or suffered damage.
- The defective Abiomed Impella Heart Pump left the patient with severe injuries or resulted in the patient’s death.
Taking the first steps toward filing a lawsuit can be intimidating, especially against a large corporation like Abiomed. However, a team of Impella Heart Pump injury attorneys can provide much-needed insight on whether you or your family can take legal action.