Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable medical devices, and the U.S. Food and Drug Administration (FDA) has blamed Abiomed’s Impella heart pumps for dozens of deaths.
Even when issues with Abiomed’s Impella heart pumps are not fatal, they can still present risks for life-altering consequences. Patients who receive heart pump implants rely on these devices to deliver oxygen throughout their bodies. As a result, when a defective heart pump fails, the clock starts ticking, and patients will often need to make extremely difficult decisions about whether to undergo high-risk surgical procedures or focus on managing the effects of their defective implants.
“For patients who have Abiomed Impella heart pumps, learning that their implants are defective can be devastating. In many cases, patients who rely on their heart pumps will be too weak to undergo revision surgery, and they will face the very real prospect of their defective implants leading to fatal complications.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.
Despite the well-known risks (and pending lawsuits) related to Abiomed’s defective Impella heart pumps, the FDA is yet to advise surgeons against implanting these devices in most cases. In the latest Impella recall notice, for example, the FDA makes clear that the recall is a “correction” and not a product removal, and it advises surgeons to, “[c]arefully position the pump catheter during operative procedures,” and “[u]se special care when inserting the pump catheter in patients with certain high risk conditions.” With this in mind, it is critical for patients who may be in need of a heart pump to be aware of their options and the risks each of these options entail; and, for those who have already received a defective Impella heart pump, seeking treatment at the first sign of a potential concern is essential.
Understanding the Serious Health Risks Associated with Defective Impella Heart Pumps
To date, Abiomed has issued at least four recalls related to its Impella heart pumps, including all of its left sided blood pumps. These recalls, which affect approximately 75,000 devices, identify multiple serious health risks, including risks for fatal complications. Here is a brief overview of what patients and their families need to know about the Abiomed Impella heart pump recalls:
Impella Heart Pump Recall #1: Impella 5.5 with SmartAssist
Abiomed issued a recall for its Impella 5.5 with SmartAssist device on April 17, 2023. The recall covers:
- Device(s): Impella 5.5 with SmartAssist Devices with product code 0550-0008
- Distribution Dates: September 28, 2021 to March 6, 2023
- Number of Devices Recalled in the U.S.: 466
As the FDA explains, “Abiomed is recalling specific Impella 5.5 with SmartAssist sets after receiving customer complaints about purge fluid leaking from the purge sidearm of the pump. If a purge leak occurs the system will experience low purge pressures . . . . [and i]f 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.”
This is the only one of the four Abiomed Impella heart pump recalls for which the FDA recommends against using the recalled device. Even here, however, the FDA is only advising surgeons against using the recalled devices, “unless no other product is available.” As of the date of the recall, the FDA had received 179 complaints, with three reports of injuries and no reports of deaths.
Recall #2: Impella 2.5, 5.0, CP, and LP Heart Pumps
Abiomed issued a second recall covering multiple variations of its Impella-branded devices on June 14, 2023. The recall covers:
- Device(s): Impella 2.5, 5.0, CP, and LP Heart Pumps with multiple product codes
- Distribution Dates: May 1, 2021 to present
- Number of Devices Recalled in the U.S.: 7,895
According to the FDA, Abiomed issued this recall due to concerns that inadequacies in the instructions provided with the devices may lead to improper implantation or failure to recognize complications from the Impella device defects. If improperly implanted, “[t]here is a potential risk that the Impella motor housing may come into contact with the distal stent of a transcatheter aortic valve replacement (TAVR). The contact may damage or destroy the motor’s impeller blades . . . . 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.”
The FDA also warns that if one of these Impella heart pumps fails, “[t]here is a risk that pieces of the broken blades could enter the patient’s blood stream.” This can present life-threatening risks as well; and, as of the time of the recall, the FDA had received reports of 26 injuries and four deaths.
Recall #3: Impella RP Flex with SmartAssist
Abiomed issued a recall for its Impella RP Flex with SmartAssist device on June 29, 2023. The recall covers:
- Device(s): Impella RP Flex with SmartAssist with multiple product codes
- Distribution Dates: November 1, 2022 to present
- Number of Devices Recalled in the U.S.: 65
The recall of Abiomed’s Impella RP Flex with SmartAssist device also relates to issues with the device’s Instructions for Use (IFU). While stating that, “clinicians may continue to use the devices,” the FDA warns that the devices IFU, “do not appropriately address precautions for health care providers to take when treating patients whose anticoagulation clotting time is below the recommended value.” Issues with Abiomed’s Impella RP Flex with SmartAssist devices have been blamed for at least a dozen injuries, with no reports of death as of the date of the recall.
Recall #4: Impella 2.5, 5.0, 5.5, CP, and LP Heart Pumps
Abiomed issued a fourth recall for its Impella heart pump devices on December 27, 2023. This is the broadest of the recalls by far, and it is the recall that spurred the current wave of Abiomed Impella lawsuits. The recall covers:
- Device(s): Impella 2.5, 5.0, 5.5, CP, and LP Heart Pumps with multiple product codes
- Distribution Dates: October 10, 2021 to October 10, 2023
- Number of Devices Recalled in the U.S.: 66,390
As summarized by the FDA, the latest Abiomed Impella recall involves concerns that, “the pump catheter may perforate (cut) the wall of the left ventricle in the heart.” If this happens, it can lead to, “serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”
When the FDA published its recall notice earlier this year, the defective devices covered by this recall had already been blamed for 129 reported serious injuries, including 49 deaths. However, based on what we now know, the total injury and death toll of Abiomed’s defective heart pumps is likely much greater.
All four of the Impella heart pump recalls are Class I recalls. The FDA issues a Class I recall when there is, “a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” This underscores the significant risks associated with Abiomed’s defective Impella heart pump devices—as well as the need for patients to seek medical advice promptly if they have any questions or concerns about their Abiomed implants.
Understanding the Substantial Costs Associated with Defective Impella Heart Pumps
Of course, with our modern healthcare system in the U.S., substantial health risks also come with substantial costs. Patients and families affected by defective Abiomed Impella heart pump implants can face extreme medical bills that far exceed their ability to pay. When Abiomed Impella heart pump defects prove fatal, families can face additional costs for funeral, interment, and other services during their times of suffering.
These are all costs that patients and families can—and should—seek to recover from Abiomed. As noted above, the company is currently facing lawsuits across the country from patients and families affected by its defective Impella heart pump devices. In these lawsuits, patients and families are seeking compensation not only for their financial costs, but for their non-financial costs as well. While individual circumstances vary, recoverable losses generally include:
- Patients’ medical expenses and other out-of-pocket costs (including costs for revision surgery and rehabilitation)
- Families’ funeral and interment expenses when Abiomed Impella heart pump implant defects lead to death
- Pain, suffering, and emotional trauma
- Loss of income, benefits, and inheritance
- Loss of companionship, consortium, services, society, and support
Patients and families who file Abiomed Impella lawsuits can seek compensation for their specific losses. These losses may range from tens of thousands to millions of dollars. For those who are thinking about filing a lawsuit, informed decision-making is critical, and this starts with engaging a lawyer who can assess the potential value of your claim and help you determine whether it makes sense to move forward. Learning about your legal rights should cost you nothing; and, if you decide to file a lawsuit against Abiomed, your legal fees (if any) should be calculated as a percentage of your financial recovery.
