Our firm has been following the Impella recall from day one. Here is each Impella recall to date we found online. (The dates reflect content current as of dates on FDA’s site).
- Impella CP with SmartAssist devices after nine pumps in a single lot failed inspection but were inadvertently released to customers. Using affected pumps may lead to unexpected pump stops or release of potentially harmful particulates. (8/12/24)
- The pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle. (3/21/24)
- Abiomed is recalling the labeling for Impella RP Flex with Smart Assist System Catheter because 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. Patients with central venous lines and cardiac cannulas with systemic anticoagulation below IFU recommendation of 160-180 seconds are most at risk. (8/17/24)
- Impella recall based on 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, prompting alarms and requiring evaluation. 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. (6/5/23)
- Abiomed is recalling the Impella Left Sided Blood Pumps because the pumps’ Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR). (7/27/23)
As experienced product liability lawyers, we recognized the severity of this issue. We knew families would lose loved ones and our personal injury lawyers would need to rise to help families who lost someone due to the issues raised in the Impella recall. The Impella recall is driving several potential Impella lawsuits.
At least 129 Injury Reports and 49 death Reports Led to the Impella Recall
Companies and FDA do their best to prevent dangerous products from reaching patients. Mistakes happen. After medical devices hit the market, injuries sometimes occur. Patients and doctors should report injuries and deaths associated with medical devices. When they do, we learn of risks and can prevent harm. Such is the case with the Impella recall.
Here, there were 129 injury reports. Additionally, there were 49 reports of death. News reports of these injuries abound online. As patients learn of the recall and connect the dots, impella lawsuits will emerge.
The Abiomed Impella Recall and Impella Lawsuit: What You Should Know and Do
Abiomed, Inc. made a medical device called the Impella. As the manufacturer of the Impella heart pump, it recalled the product. Because of the Impella recall, it now faces a growing number of lawsuits after issuing multiple recalls for its life-support products. The Impella recall has helped families understand why their loved one was taken.
These Impella heart pumps, designed to assist critically ill patients, can cause serious injuries and fatalities due to defects and malfunctions per the Imeplla recalls.
If you had a heart device and a complication, particularly if you are impacted by the Impella recall, call us at 855-KBA-LAWS (522-5297). Or, find out if it was an Imeplla device. An Impella heart device may have injured you or your loved one; to find out, lean on experience.
KBA’s Impella Attorneys Understand the Impella Recall and the Impella Lawsuit Challenges
At KBA Attorneys, we have been investigating the dangers associated with Abiomed’s Impella devices for some time. From the first Impella recall to the most recent Impella recall, we have been on it. As the risks of these defective medical devices become more widely known, the number of patients and families seeking justice continues to increase.
We studied and reported the Impella recall early. Having worked Impella recall cases, we have the knowledge about it, and the experience as medical device attorneys, to help you navigate the Impella recall.
If an Impella device caused you or a loved to experience complications, it’s essential to understand your rights and options for pursuing compensation. Turn to the authority on medical device cases, the experienced Impella lawyers.
Contact our medical device attorneys today. Our Impella attorneys will bring decades of experience to your specific case. Medical device cases like the Imepella lawsuit are complex. The Ineplla recall raises complicated medical, specific, and legal issues. You need to speak with KBA because of our experience.
Our medical device lawyers have reviewed millions of pages of documents in cases like this. We depose corporate officers and industry experts. We litigate hard, and are smart and innovative about how try cases before juries. And we’re truly client centered.
Our legal team will obtain the records needed, evaluate the medicine and science, and learn your story, understand your experience. If the Impella recall impacted your family, let us help.
With a complex case like Impella, given the risks involved, you need to contact us to get the best results via the KBA expertise.
The Risks Associated with Abiomed’s Impella Device
Impella risks are real. The Impella recall makes that clear.
Abiomed’s Impella heart pumps maintain blood flow in patients with severe heart conditions, often during critical procedures. However, the Impella devices can cause severe complications, including:
- Left ventricle perforation
- Lack of blood flow
- Hypertension
- Fatal injuries
- Repeat procedures to position the device
These issues have resulted in multiple recalls of the Impella heart pump devices. The Impella recall is serious. The U.S. Food and Drug Administration (FDA) issued Class I recalls of the Imeplla device. The Class I Impella recall is the most serious category. This Imeplla recall level concerns products that pose a high risk of severe injury or death.
What are the risk of the Impella device specifically?
From what we know of the Impella recall, and our review of Impella heart pump caes, here are some risks. First, the Impella device may perforate the valve. Second, the Imeplla heart pump presents positioning problems.
A surgeon must implant the Impella device. Surgeons are skilled professionals and some use robots. But neither are perfect. They rely on the medical device company to design products that are sufficiently easy to use given the difficulties of surgery and to provide instructions for use that they can follow to implant the Impella device properly. The Impella heart pump is small. Tinkering with it too much can mess up the motor, which in turn, can cause problems. Indeed, some patients may have had multiple procedures to position the Impella device. These are but some of the risks associated with the Impella device and Impella recall.
With the stakes of his high, you need an authority – a firm the other side will be able to see knows how to put a case like this together. An Impella recall attorney can bring an Impella lawsuit, if you qualify.
If you or a loved one had an Imeplla device, you need to speak with KBA. You want a firm that has sat across the table from medical device companies. Deposed them. Negotiated with them. Tried cases against them. Medical device companies operate within a regulated industry. We have worked within that industry as professionals before law school and as lawyers. These companies are at the cutting edge of science and medicine. There’s a finite universe of experts capable of and willing to testify in complicated cases like this.
KBA Attorneys knows how to harness a network and put the case together. And your Inpella attorney needs to understand your particular experience, make sure you’re not just a number, and be there for you throughout the process. No one is better than KBA at covering both sides of the equation. Contact an Impella law firm today to learn about the Impella lawsuit and to see if your experience is a qualified Impella device claim from an Impella recall.
Specific Impella devices impacted by the Impella recall include:
- Impella 2.5
- Impella 5.0
- Impella 5.5 with SmartAssist
- Impella CP and Impella CP with SmartAssist
- Impella LD
- Impella RP Flex with SmartAssist
Combined, the Impella recall involves tens of thousands of units. Abiomed distributed Impella across the United States. Surgeons use the Impella implant in critical cardiac procedures. Patients and healthcare providers were often unaware of the risks the Impella device posed. Impella complications occurred later and caused the Impella recall.
If you had Impella, speak with a compassionate legal team that will explain the process, evaluate your individual Impella case, and advocate for your Impella claim.
Signs of Impella Device Failure
Patients implanted with an Impella heart pump may experience device failure immediately or weeks to months after implantation of the Impella implant. Common warning signs if an Impella failure include:
- Chest pain or discomfort
- Dizziness, nausea, or vomiting
- Shortness of breath
- Abnormal heart rhythms or loss of blood pressure
- Swelling or cold extremities
- A “pins and needles” sensation in the body
And Impella failure can cause these Impella complications. You need to see if the Impella recall resulted in an Impella failure and if you’re eligible for an Impella lawsuit led by a top-notch Impella lawyer.
These Impella device symptoms can indicate serious medical complications. An Impella device injury can include life-threatening conditions. If you or someone you know is experiencing these symptoms after receiving an Impella device, it is crucial to seek medical attention immediately. Contact an Impella attorney right away concerning your possible Impella recall claim.
Impella Lawsuits against Abiomed
Patients and families across the country may file lawsuits against Abiomed concerning the Impella device. Impella lawsuits will likely allege the company’s defective Impella heart pumps caused injuries and, in some cases, deaths. The Impella device lawsuits will also claim that Abiomed failed to properly test the Impella implant, ignored potential Impella safety risks, and neglected to provide adequate warnings about the Impella complications and Impella risks.
Those pursuing legal action seek compensation for:
- Medical expenses, including hospitalization and corrective procedures
- Loss of income due to inability to work
- Pain and suffering caused by complications
- Emotional distress for patients and their families
- Funeral expenses and other losses in cases of wrongful death
These cases may lead to multi-district litigation (MDL), a legal process that consolidates similar lawsuits to streamline proceedings while allowing plaintiffs to seek compensation tailored to their individual damages. Unlike class action lawsuits, MDLs allow each claimant to recover based on their unique circumstances. This can result in higher net settlements for victims.
Right now, KBA is pursuing individual Impella lawsuits from the Impella device recall. Each case is different, so contact us to see if you qualify for an Impella claim and if we will choose to represent you and bring the KBA expertise to your potential Impella device claim.
Why You Should Take Action Now Concerning Impella
The Impella recall may start the time clock. If an Impella device has impacted you or your loved, it’s important to act quickly. Each state has a statute of limitations that limits the amount of time you have to file a lawsuit.
Once this deadline passes, you may lose your ability to recover compensation, no matter how severe your injuries or losses. We expect the Defendants will try to say the Impella recall starts the clock. Here’s how you can get started on your Impella recall claim.
Obain your medical records if you can. See what model Impella you had. Check it against the Impella recall. Evaluate the outcome to see if complications associated with Impella apply. Or let us do all the work for free – we only get paid and recover expenses if we obtain monetary compensation for your. We’ll figure out if the Impella heart pump you had was an Impella device subject to the Impella recall.
Consulting an attorney promptly ensures that you understand your rights and preserves your ability to take legal action. It takes time to gather the evidence and develop your specific case; hence why we keep writing – contact us – and giving you the form in this informational piece. At KBA Attorneys, we have experience in handling complex medical device cases and can guide you through the legal process to maximize your chances of recovery.
KBA Attorneys: Advocates for Victims of Defective Heart Devices Beyond the Impella Recall
KBA handles heart-related medical devices. We are preeminent, nationally-recognized medical device lawyers. KBA Attorneys has been investigating Abiomed’s Impella device recalls and related Impella lawsuits for some time. We know the case. Our legal team led by experienced product liability attorneys has a proven track record of holding medical device manufacturers accountable for their negligence.
Here are some past blogs we have written about Abiomed’s Impella Heart Pump:
FDA Announces Major Recall of Impella Heart Pumps for High Injury Risk
We focus specifically on defective medical devices, including heart-related implants and equipment. Our expertise in this area allows us to thoroughly investigate claims, consult with seasoned medical experts, and build strong cases on behalf of our clients. Contact us now regarding Impella.
The Importance of Accountability
When medical device manufacturers prioritize profits over patient safety, the consequences can be devastating. By holding Abiomed accountable for the harm caused by its defective Impella heart pumps, victims and their families can not only seek justice but also help prevent future harm to others. Legal action against Abiomed sends a clear message that negligence in the medical device industry will not be tolerated. The Impella recall must have consequences.
How we Got Here: The Impella Heart Pump Approval
In thinking about the Impella heart pump and accountability, some ask, how did we get here? Why was this product approved? Medical devices get to the market via two primary pathways through FDA. We provide some information on our medical device page here:
FDA approved the Impella heart pump. Here is one such PMA:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140003s005. You can read a summary of the safety and efficacy from 2016 here. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S005B.pdf. Here is some clinical background on the Impella heart pump. https://pmc.ncbi.nlm.nih.gov/articles/PMC6679960/. After being on the market for a while, there were some recalls, like this one. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks
Contact Us Today
If you or a loved one has been harmed by an Abiomed Impella heart pump, don’t wait to seek legal assistance. At KBA Attorneys, we are here to answer your questions, explain your rights, and help you pursue the compensation you deserve.
To learn more about how we can assist you, contact us today for a free consultation. Let us help you take the first step toward justice and recovery.
Closing Thoughts
Defective medical devices like Abiomed’s Impella heart pumps may pose serious risks to patients and their families. At KBA Attorneys, we are dedicated to helping those affected by these dangerous products navigate the legal process with confidence and compassion. If you believe you have a claim, don’t hesitate to reach out to our team. Together, we can work to hold Abiomed accountable and secure a safer future for all patients.