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A small cardiovascular device came to the rescue of people with heart diseases, pumping hopes back into their lives with its debut. Soon after its arrival, controversies on its efficacy and defects started hovering over it. Reports of injury and death made the manufacturer Abiomed to recall its much-lauded heart pumps.
Is Impella dangerous? What is the controversy? Why people are filing Abiomed Impella heart pump lawsuits? Before delving into the device’s safety and the controversies around Impella, let’s know the function of Impella devices and the reasons led to the recent recalls and lawsuits.
What is Abiomed Impella heart pump?
According to Abiomed, the Impella heart pump “is designed to enable the heart to rest and recover by improving blood flow and/or temporarily assisting with the pumping function of the heart.” Impella heart pump is a percutaneous catheter that helps people with heart diseases by supporting heart in pumping blood.
Claiming to be the “World’s Smallest Heart Pump,” the Abiomed Impella heart pump with smart assist came to the market with the FDA approval in 2018. Other versions of heart pumps from Impella hit the market long before that.
What is Abiomed Impella heart pump used for?
This device is used temporarily to assist the heart to rest while recuperating from injuries, infections or surgeries. It can render support to people “with severe coronary artery disease requiring high-risk PCI or AMI cardiogenic shock,” as claimed by Impella manufacturers.
Do you know how Impella heart pump works?
The heart pump is inserted through a small opening (incision) and progressed through the arteries into the heart. The heart pump draws blood from the left ventricle and pushes it into the aorta, by providing support in pumping blood. This process promotes the blood flow to all major organs. When the patient doesn’t need the pumping support any more, the cardiologist will remove the heart pump.
What are the disadvantages of Impella?
Though Impella is claimed to give effective support for people with heart complications, it has some disadvantages too. It could provide only a shorter duration of support (5 to 7 days) but in some cases physicians have to prolong its use while the patient waits for implants or organ donation. It also poses frequent cannula dislodgement, reduced blood flow in the lower extremity (ischemia), and difficulty during transport to other care centers.
History of Abiomed- in a Nutshell
Abiomed is a leading power in providing heart, lung and kidney support technologies to the world. It was founded in 1981 for developing artificial heart. It acquired Impella Cardio Systems in Aachen, Germany in 2005.
Later on December 22, 2022, Johnson & Johnson MedTech acquired Abiomed for $16.6 billion. Abiomed manufactures devices like Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist, Impella RP, Impella RP Flex, and Impella RP Flex with SmartAssist.
FDA Approvals for Abiomed Products
- 1992– BVS 5000®, the first ventricular assist device
- 2008– Impella 2.5 heart pump got 510(k) clearance
- 2009– AB Portable Driver received approval and Impella 5.0® and Impella LD® heart pumps got 510(k) clearance
- 2012– Impella CP heart pump received 510(k) clearance
- 2015– PMA approval to Impella 2.5 for elective and urgent high-risk procedures
- 2016– Impella CP® got expanded PMA approval for high-risk PCI procedures
- 2017– PMA approval for Impella RP for right heart failure
- 2018– Smart Assist for Impella 5.5 approved
- 2021– Impella ECP™ got breakthrough device designation and Impella RP® with SmartAssist® for right heart failure
- 2022– Impella Low Profile Sheath got 510(k) clearance
Complications of Impella heart pumps
According to the information found in Abiomed’s website, their Impella heart pumps could cause adverse side effects as noted below:
Abiomed Impella Heart Pump Recall- Controversy Behind
On April 17, 2023, Abiomed sent a letter requesting the physicians and facilities who purchased its Impella 5.5® with SmartAssist® System that it is recalling the product following complaints from consumers. Around 460 devices were recalled.
The issues noted in the letter were as follows:
Damage to the side arm due to the interaction of sodium bicarbonate with purge sidearm leading to purge fluid leak was noted as the main cause for the recall. This may further lead to pump stopping its function and failing to render the support the patient needs in pumping the blood.
The FDA issued a Class I recall on Abiomed Impella heart pump on June 14, 2023. Class I recalls are issued when defective medical devices could cause serious injuries or death. The recall includes around 8,000 units of the pump, distributed from May 1, 2021, to the present.
The left sided Impella heart pumps were recalled for the risk of motor damage after contact with Transcatheter Aortic Valve Replacement (TAVR) Stent. The list of devices recalled with Product Names and Product Codes are listed below:
- Impella 5.0 Blood Pump, Product Number 005062
- Impella CP Blood Pump, Product Number 0048-0032
- Impella 2.5 Blood Pump, Product Number 005042
- Impella CP with SmartAssist Blood Pump, Product Numbers 0048-0024, 0048-0045, 1000080
- Impella LD Blood Pump, Product Number 005082
- Impella 5.5 with SmartAssist Blood Pump, Product Numbers 0550-0008 And 1000100
The providers were asked to install the Impella system carefully on patients with TAVR. They were warned not to reposition it while it’s running. The device should be turned to P0, for any movements close to the valve stent. If a TAVR patient on Impella showed low flow, they should consider impeller damage and quickly change the pump.
Abiomed had reported around “30 complaints, 26 injuries, and four deaths,” from their systems to the FDA.
They also warned that, “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. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream.”
On June 29, 2023, Abiomed recalled Impella RP Flex with SmartAssist devices distributed from Nov. 1, 2022, to the present due to purge fluid leak. It also recalled the labeling for Impella RP Flex with Smart Assist System Catheter as the label did not provide adequate warning about the blood clot risks to patients with anticoagulation clotting time below the recommended value of 160-180 seconds.
In a warning letter sent to Abiomed on September 19, 2023, the FDA warned that they should get proper approval for their Impella Connect System (smart assist) as it is a separate device.
Abiomed recommended some instructions to be followed in the Important Medical Device Advisory letter.
Abiomed Impella Heart Pump Lawsuits
Johnson & Jhonson is facing Abiomed Impella Heart Pump Lawsuits in the recent times for the defects, injuries and deaths encountered by the consumers. Attorneys are investigating the issues around these medical devices and the possibility of lawsuits.
Lawsuits and settlements are not new for Abiomed. They faced lawsuits alleging that they tried to influence doctors to purchase their Impella heart pumps. Abiomed settled those lawsuits for $3.1 million in March 2018.
While the old lawsuits were for their marketing strategies, the newly emerging Abiomed Impella heart pump lawsuits come under either personal injury or wrongful death.
March 2024 Update
According the New York Times, Abiomed Impella heart pumps are linked to heart wall perforation and around 50 deaths. Many studies have proved that these heart pumps can perforate the heart walls and heighten the risk of death in patients with poor heart conditions.
Abiomed had published a warning in its website in October 2021, noting the heart wall perforation risk as a rare condition. However, it had failed to inform the FDA on the same. Since October 2021, the agency had received 21 addition cases of heart wall tears leading to deaths.
In March 2024, the FDA sent an alert to be cautious of the heat wall tear risk. However, it had not initiated any recall but only a warning on the use. The company had warned earlier that improper operator handling could damage delicate heart tissues.
The Abiomed Impella heart pump lawsuits are still in the cradles and no trial dates are scheduled yet in 2024.
Can you file an Abiomed Impella heart pump lawsuit?
If you or your loved one was injured due to the defective Impella heart pumps, you stand a chance to file a claim. People who incurred severe injuries, such as brain damage due to lack of blood flow, and required open-heart surgery to remove the device or its fragments have bright chances to bring Abiomed to face the consequences for their negligence.
The legal implications of these findings are significant. Individuals who believe they have suffered harm or complications due to the Impella Connect System’s operation might be entitled to seek legal redress. This can include claims for damages covering medical expenses, pain and suffering, loss of consortium, lost wages, and potentially punitive damages.
Victims who wish to pursue lawsuits should consult defective Impella heart pump lawsuit attorneys to know the chances of their claim. A thorough scrutiny of their medical records can provide valuable insights to bolster their claims. Getting an experienced medical record review company to shoulder your record analysis gives a strong foundation for your legal battle.
To wrap up,
Abiomed Impella heart pump lawsuits are still in the infancy. As the outcome of the investigations and further study reports to support the claims of the plaintiffs are not available, we could not predict their legal course. However, if more plaintiffs come forward with more Abiomed Impella heart pump lawsuits, it can turn the attention of the public, media and judicial system in favor of the affected.
Let’s hope the victims find some kind of resolution for their woes in 2024 itself.
