Wilmington Impella Heart Pump Lawyers
Impella heart pumps have a documented history of causing injury or death in hundreds of patients, prompting the U.S. Food and Drug Administration (FDA) to issue its most serious class of recall warnings. Currently, 66,000 heart pumps are in distribution in the United States, with documented dangers reported as early as 2021.
What Are Impella Heart Pumps?
The Impella heart pump is a temporary medical device used in patients whose hearts cannot pump enough blood following a heart attack, open heart surgery, heart disease, or cardiomyopathy. The device is manufactured by Abiomed, a Johnson & Johnson MedTech division. The pump is a straw-like device, surgically inserted through the heart’s major blood vessel into the left ventricle, the heart chamber responsible for pumping blood throughout the body. Once implanted, the device helps transport blood through the heart and reduces the organ’s workload by allowing it time to recover and heal.
Why Are Abiomed Impella Heat Pumps Being Recalled?
Abiomed first discovered the Impella heart pump’s risk of perforation in October 2021, issuing a technical bulletin warning physicians of the risk and additional instructions on positioning the device to reduce the risk of perforation. However, Abiomed did not share the warning with the FDA. Had the FDA received the appropriate notice, it would have warned hospitals and doctors about this risk. Some people who have the device now have to live in fear it will malfunction.
Months later, FDA officials found the bulletin during a routine inspection of the company’s U.S. headquarters in Massachusetts, prompting them to issue the company a warning letter. The letter prompted Abiomed to recall the device’s instruction manual and issue revised instructions for using the heart pump. A series of recalls ensued over several months:
- April 2023: Abiomed recalled certain Impella 5.5 heart pumps with SmartAssist following 179 complaints of fluid leaking from the purge sidearm, resulting in three reported injuries. According to the recall, persistent low purge pressure and purge flow leakage may result in the pump’s failure. For critical patients, pump failure could lead to further deterioration and worsening of their already critical condition or possible death.
- June 2023: Following reports of 26 injuries and four deaths, Abiomed issued a Class 1 recall of 7,895 Impella Left Sided Blood Pumps due to the risk of motor damage, the most serious type of medical device recall. The company reported that contact between the heart pump and Transcatheter aortic valve replacement (TAVR) stents implanted in certain patients can damage or destroy the Impella motor’s impeller blades. Such damage could result in left ventricle perforation or wall rupture, hypertension, lack of blood flow, and death.
- December 2023: Abiomed issued an Urgent Medical Device Correction letter, alerting healthcare facilities who purchased their heart pumps to the device’s potentially dangerous risks. Abiomed encouraged facilities to notify all necessary personnel and any other facilities they provided with the devices. The letter also included instructions urging physicians to adhere to the following new and revised product warnings:
- Use extreme care when positioning the heart pump catheter during surgery.
- Use imaging when advancing or torquing the pump catheter.
- Use special care when inserting the pump catheter in high-risk patients or during active cardiopulmonary resuscitation (CPR).
- Review the updated warnings in the device “Instructions for Use.”
- March 2024: The FDA issued a recall of Impella heart pump instructions for use following 129 reported injuries and 49 deaths due to incorrect positioning. The injuries and deaths resulted from doctors accidentally puncturing the heart while implanting the device, based on Abiomed’s instructions. The alert is classified as the most severe action possible for products capable of causing serious injury or death without removal from the market. Despite its severity, the FDA is allowing the device’s continued use, provided Abiomed updates to the 243-page instruction manual, including the device’s associated risks and updated instructions on positioning during installation.
Which Abiomed Impella Heart Pump Models Are Being Recalled?
The FDA recall includes Impella heart pumps manufactured and distributed in the United States between October 2021 and October 2023 and includes the following heart pump models:
- Impella 2.5
- Impella CP
- Impella CP with SmartAssist
- Impella 5.0
- Impella 5.5 with SmartAssist
- Impella LD
What Injuries Can Be Caused by Defective Impella Heart Pumps?
Defective Impella heart pumps pose a serious risk of the pump’s catheter perforating, or puncturing, the heart’s left ventricle wall, resulting in potentially serious or fatal injuries, such as:
- Brain damage
- Complete pump failure
- Death
- Fracturing of the heart pump impeller blade, causing additional injuries
- Heart perforation
- Hypertension (high blood pressure)
- Internal bleeding
- Loss or lack of blood flow
- Organ damage
Can I File a Lawsuit for My Impella Heart Pump Injuries?
If you or a loved one was severely injured or died as a result of the Abiomed Impella heart pump, you may be eligible to file a lawsuit for compensation. An experienced Wilmington Impella heart pump injury lawyer can review the specific details of your circumstances and determine whether you have a case. You may be eligible if you or a loved one meet the following criteria:
- Underwent heart valve replacement surgery in which the doctor reported pump failure or damage during the procedure.
- Suffered brain damage or other serious injury due to lack of blood flow.
- Required an operation during a heart attack or cardiogenic shock involving the use of a heart pump.
- Experienced the loss of a loved one due to a defective heart pump.
How Can Jacobs & Crumplar, P.A. Help Me With My Impella Heart Pump Injuries?
Individuals who have suffered severe injuries or lost a loved one due to the Abiomed Impella heart pump may be entitled to file a product liability lawsuit against the company. Medical device cases can be exceedingly complex, and it is imperative to consult an experienced lawyer before taking any action. At Jacobs & Crumplar, P.A., our Wilmington Impella heart pump injury lawyers have decades of experience handling defective medical device cases. We can assist you in the following ways:
- Assessing the circumstances of your case to determine whether you have a viable claim and the extent of your damages.
- Review your medical records.
- Consult with your medical team regarding your current and ongoing care.
- Prepare all documentation, evidence, witness, and physician statements, and file a lawsuit on your behalf or a wrongful death lawsuit on behalf of lost loved ones.
- Hire medical experts to testify.
- Negotiate with opposing counsel for maximum compensation.
- Represent you in court should the case go to trial.
The compensation you recover depends on the type and severity of injuries you sustained and may include past and future medical treatment, loss of income, and pain and suffering. Jacobs & Crumplar, P.A. has a history of winning and has recovered over half a billion dollars in compensation for our injured clients.
Our Wilmington Impella Heart Pump Injury Lawyers at Jacobs & Crumplar, P.A. Can Help You Today
If you have suffered an injury or lost a loved one due to an Abiomed Impella heart pump, Jacobs & Crumplar, P.A., can help you seek justice. Call our Wilmington Impella heart pump injury lawyers at 302-656-5445 or contact us online to schedule a free consultation. Our offices are located in Wilmington and Millsboro, Delaware, and we represent clients in Dover, New Castle County, and Sussex County.