Nadrich Accident Injury Lawyers is representing those who have been seriously injured by Abiomed Impella heart pumps, as well as representing the families of those who have died after an Impella heart pump was used on them.
Our Abiomed Impella heart pump lawyers have been handling defective medical device claims since 1990 and have recovered more than 0,000,000 for clients. Our vast experience in handling cases involving medical devices means that we can recover the most compensation possible for your Impella device injuries.
We are handling cases involving Impella pumps on a contingency fee basis, meaning we won’t charge you any fee to handle your case until and unless we recover financial compensation for you. You’ll only be charged a percentage of any recovery we obtain for you. You won’t be charged an upfront fee or any out-of-pocket fees.
If you’ve been seriously injured by one of these heart pumps and can’t afford treatment for your injuries, we can get you to doctors who will treat you on a lien, which means you won’t be charged any fees for treatment until your case ends. Doctors do this for our clients because they trust us to get great results for our clients, since we have a long track record of doing so.
Call us today for a free consultation, fill out this page’s free case evaluation page or text us from this page if you or a loved one has suffered serious injuries or died due to an Impella heart pump. You might qualify for financial compensation.
Abiomed Impella Heart Pumps Recalled, Linked With Serious Adverse Health Consequences
On December 27, 2023, Abiomed recalled Impella pumps’ usage instructions due to the risk of left ventricle perforation. However, this was actually the fourth recall in 2023 for the Impella pumps. In addition, in October 2023, the FDA said it had sent Abiomed a warning letter, saying its responses to a manufacturing facility inspection were inadequate, and that the company was marketing the Impella Connect system despite not having the proper premarket approval.
December 27, 2023 Recall
The affected Impella pumps in this recall were:
- Impella CP
- Impella 2.5
- Impella CP with Smart Assist
- Impella 5.0
- Impella LD
- Impella 5.5 with Smart Assist
These left-sided blood pumps are used to support the heart’s pumping chambers on a short-term basis during catheter-based procedures which carry a high risk known as percutaneous coronary interventions. The devices are also used when an ongoing risk of cardiogenic shock occurs due to a severe heart attack, when they heart isn’t working well because of cardiomyopathy, or due to open-heart surgery. The devices work by helping the heart in pumping blood, giving the heart some time to recover.
This recall involved updating the devices’ instructions for patient safety, adding new and revised warnings to the instructions, since it was discovered that a pump catheter might lead to heart perforation (a cut) in the heart’s left ventricle wall.
The FDA stated that usage of these pumps may cause:
- Left ventricle perforation
- Free wall rupture
- Reduction of blood flow
- Hypertension
- Death
As of March 21, 2024, there were 129 serious injury reports which included 49 death reports, according to the FDA.
June 29, 2023 Recall
This recall affected the Impella RP Flex with SmartAssist.
This device is a device which is used for a period of up to 14 days. It is used in patients who end up with acute right heart failure following the implantation of a left ventricular assist device. This device is placed through the internal jugular vein, supporting the heart’s right chamber via the pumping of blood.
This device’s labeling was recalled since its usage instructions failed to properly address precautions intended for healthcare providers regarding the treatment of patients with inadequate anticoagulation clotting time.
The FDA said that the use of these catheters might lead to severe health consequences, including:
- Particle deposits forming
- Blood clots
- Death
As of August 17, 2023, 12 injuries had been reported regarding this device, with no death reports.
June 14, 2023 Recall
This recall affected the same six devices as the December 27, 2023 recall.
The reason for the recall is that the usage instructions for the devices failed to properly address the right precautions doctors should take when treating patients with transcatheter aortic valve replacements. The usage instructions failed to guide doctors regarding how to manage Impella usage in patients who have these valve replacements, failing to describe that the motor housing of the device might contact one of these valve replacement’s distal stent, destroying or damaging the impeller blades of the motor.
When this damage occurs, it may lead to pump stop or a reduction of blood flow, which might fail to provide the patient enough support, or delay therapy. This may threaten the life of those who need high support levels, and may cause broken blade pieces to enter patients’ bloodstreams.
According to the FDA, as of July 27, 2023, 26 injuries and four deaths had been reported regarding this issue.
April 17, 2023 Recall
This recall affected the Impella 5.5 with SmartAssist device.
This device was because customers had complained regarding the leaking of purge fluid from the pump’s purge sidearm. When purge leaks occur, the system experiences low purge pressures, which prompts alarms and requires evaluation. When the leak issue isn’t resolved, pump stop, as well as loss of therapy may occur. In critical patients, this can cause further deterioration and a worsening of a critical condition, which may lead to severe injury or death.
According to the FDA, as of June 5, 2023, there had been three injuries and zero deaths related to the issue.
Compensation Available In An Impella Lawsuit
If you or a loved one suffered serious injury or death due to an Impella heart pump, you may qualify for financial compensation for:
Medical Bills
If you have already accrued medical expenses due to these heart pumps, you may qualify for financial compensation for those bills. In addition, if you require future medical treatment due to these heart pumps, you might be eligible for financial compensation for any bills related to that future treatment.
Lost Wages
If you were injured by one of these heart pumps and were either unable to work due to your injuries or had to take time off from work to have your injuries treated, we can help you recover financial compensation for the wages you were unable to earn as a result.
Loss of Earning Capacity
If you suffered a disability due to one of these devices, we can help you recover financial compensation for the loss or reduction of earning capacity caused by that disability.
Pain and Suffering
We can place an accurate value on the physical pain and mental suffering you went through as a result of the use of one of these devices, ensuring you’re adequately compensated for this pain and suffering.
Wrongful Death
If you lost a loved one due to the use of one of these devices, unfortunately no amount of financial compensation will be able to bring your loved one back. However, financial compensation can help make sure your family doesn’t have to go through financial distress as a result of the loss of your loved one. We can help you recover compensation for:
- The grieving and suffering you’ve gone through
- Your loved one’s pain, suffering, medical expenses, burial expenses and funeral costs
- The loss of your loved one’s consortium, companionship, love, household services and income
What Can Nadrich Accident Injury Lawyers Do for You?
As defective medical device lawyers, our role is to advocate for you after you or a loved one has been injured or killed by a defective product. We possess the skills, experience and knowledge to handle complicated defective medical device cases and fight for compensation for your losses. Our primary responsibilities and roles include:
Evaluating Cases
We will assess your potential case to determine if you have a valid defective medical device claim. We will review the evidence, circumstances and facts surrounding your damages or injury to determine if they were substantially caused by a heart pump’s product defect.
Guiding You Through the Legal Process
We will provide you with expert legal guidance, explaining your options and rights regarding the laws of product liability. We will help you understand the lawsuit process, possible outcomes, as well as the best course for you to take based upon your case’s specifics.
Determining Liability
One of our most crucial tasks is the determination of who is legally liable for medical devices’ defects. This could include the manufacturer, retailer or distributor of a product. Identifying which parties are responsible is vital for you to pursue appropriate product liability or negligence claims.
Establishing That Products Are Defective
We will work to prove that a product defect existed and demonstrate your damages or injuries were caused by that defect. We may use industry standards, expert testimony and evidence to support your claim.
Pursuing Financial Compensation
We will seek to recover fair financial compensation for your damages, which might include lost wages, medical bills, mental anguish, pain and suffering, wrongful death and more. We will fight hard to perform negotiations with insurance companies or represent you in court in order to secure for you the best outcome possible.
Abiomed Lawsuit Updates
August 14, 2024 Update
A recall has been issued by federal health officials regarding Impella Heart Pumps. The recall was issued because nine pumps from a single lot ended up failing inspection, yet were released to customers anyways. The use of affected pumps might lead to a release of possibly harmful particulates, or unexpected pump stops.
Using the affected devices could lead to severe health consequences, including cardiovascular and heart complications like low blood pressure, stroke, bleeding, hemolysis, cardiac tamponade, a need for additional surgery, heart attack or death.
No deaths or injuries have been reported regarding the issues and none of the devices which have been recalled were used to care for patients.
Attorneys are currently investigating lawsuits related to Impella heart pumps due to a possible failure by the manufacturer to disclose adverse events it knew about, which might have stopped doctors and patients from making decisions which were fully informed regarding the pumps' safety, possibly leading to deaths or injuries. The devices have been linked with in excess of 100 fatalities and injuries which have led to FDA warnings and recalls.
May 6, 2024 Update
A new study found that Impella heart pumps may increase the risk of worsening aortic regurgitation, device failure, hemolysis, limb ischemia and bleeding.
The study found that 24 percent of patients using Impella pumps experienced:
- Worsening aortic regurgitation: An increase of blood flowing backward through an aortic valve, which worsens heart strain.
- Device failure: Pump malfunction, which risks circulatory support which is inadequate.
- Hemolysis: Red blood cells breaking down, which may cause kidney damage and anemia.
- Limb ischemia: A reduction of blood flow to the limbs, which causes pain as well as possible tissue damage.
- Severe bleeding: Excessive loss of blood which may lead to organ failure or shock.
The study found that only 6.2 percent of patients who received standard care ended up experiencing any of these adverse events.
The study also found that 41.9 percent of Impella pump users required renal replacement, whereas only 26.7 percent of patients receiving standard care required renal replacement.
April 16, 2024 Update
According to an FDA warning letter, Abiomed failed to submit MDR reports in a timely fashion to the FDA on multiple occasions, including:
- The company did not report two deaths of patients within 30 days of the date they became aware of the deaths
- The company did not report multiple incidents involving Impella device malfunctions which caused serious injuries to patients, including hemolysis, a pump stoppage and a leaking and cracked purge sidearm
It was found during an FDA inspection that the company issued a bulletin via its app and website in October 2021 which disclosed that a heart tearing risk was associated with its Impella devices. The company apparently knew about this risk since January 2018.
The warning letter from the FDA says the company should have filed a formal notice regarding the issue within a period of 10 days, but instead chose to communicate about the issue differently, choosing not to directly disclose this risk to the FDA.
According to the New York Times, Abiomed knew about at least 21 more tears of the heart wall associated with Impella devices which could have led to patient deaths in the months following October 2021.
Is There a Time Limit to File an Impella Heart Pump Lawsuit?
There will be a time limit for you to file an Impella heart pump lawsuit, and this time limit is called a statute of limitations. Failure to file your lawsuit in time may forever bar you from recovering financial compensation for your damages.
The time limit will vary from state to state, and various exceptions may apply to the time limit which may shorten or lengthen it.
The best way to find out if you qualify to file a lawsuit is to call us today for a free consultation. Calling us today also gives us the most time possible to investigate your case, build a convincing case for you and make sure any paperwork is filed on time, so don’t hesitate – call us today for a free case evaluation.
Remember: we won’t charge you any fees until and unless we recover money to compensate you for your losses.
