Impella Heart Pumps were recalled after 129 people suffered serious heart injuries, including 49 people who died, when doctors accidentally punctured their heart.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Impella Heart Pump induced injury cases in all 50 states. If you or somebody you know was injured by an Abiomed Impella Left-Sided Blood Pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is a Heart Pump?
Heart pumps, also called “blood pumps,” are medical devices that are implanted in patients whose heart is unable to pump enough blood.
There are many types of heart pumps that are designed to be used in different situations. For example, Ventricular Assist Devices (VADs) may be used as a “bridge to transplant” in patients with heart failure.
The Impella Heart Pump: An Overview
Another type of heart pump is the Impella Left-Sided Blood Pump, which is manufactured by Abiomed. This heart pump is a Left Ventricular Assist Device (LVAD) that is implanted in the left ventricle.
The Impella heart pump is advertised as “The World’s Smallest Blood Pump.” The device looks like a straw, with a powerful pump inside a long, flexible tube. Doctors use minimally-invasive surgery to insert an Impella heart pump device inside the left ventricle to help pump blood.
Surgery To Implant Impella Heart Pump
The tip of the straw-like Impella Heart Pump device is not sharp, but it can potentially puncture the wall of the patient’s heart. Doctors must be very careful to position the Impella device correctly during the operation to implant the device inside the left ventricle. Even a minor mistake can puncture a hole in the heart. This is a life-threatening emergency that must be repaired with immediate open-heart surgery.
When Do Doctors Use Impella Heart Pumps?
Impella Left Sided Blood Pumps are used for short-term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI). They also are used when there is ongoing cardiogenic shock, which occurs when the heart is unable to supply enough blood and oxygen to the organs and body.
Case Report of Impella Pump Causing Heart Perforation
In December 2021, doctors published a case report of a left ventricular free wall rupture after insertion of an Impella Left Ventricular Assist Device. The case involved a 75-year-old man who needed emergency heart surgery when the tip of the Impella device perforated the wall of his left ventricle during the insertion procedure, which caused hemorrhaging.
The doctors warned, “The IMPELLA® requires implantation of the tip in the left ventricle, but it should be noted that a fragile ventricular wall can be easily perforated.”
Why Do Doctors Use Heart Pumps?
Heart pumps may be used if the heart is too weak or injured due to a recent heart attack, an underlying heart problem like cardiomyopathy, or patients who are having a major open-heart surgery like a bypass.
Heart Pumps For Short-Term Cardiovascular Support
Heart pumps are advertised as life-saving implants that can be used in emergency situations. They are not permanent implants, but temporary devices that are implanted inside the patient’s heart. The heart pump is removed when the patient recovers from the heart attack, or has been stabilized enough to undergo another procedure.
Heart Pumps Supply Oxygen-Rich Blood To The Body
Heart pumps help reduce the workload on the heart, which gives the heart muscle time to heal and recover. The Impella Left-Sided Blood Pump is implanted inside the left ventricle, which is the strongest chamber in the heart. The left ventricle is surrounded by thick muscle because it is responsible for pumping oxygen-rich blood to the body.
Abiomed Recalls 66,390 Impella Heart Pumps
In December 2023, Abiomed recalled 66,390 Impella Left-Sided Blood Pumps due to a risk of accidental heart perforations while implanting the device. Abiomed did not pull the devices off the market, but instead updated the “Instructions For Use” with new safety warnings.
FDA Announces Class 1 Recall for Impella Heart Pumps
The FDA upgraded this to a Class 1 recall, which is the most serious type of medical device recall due to the risk of serious injury or death. According to the FDA:
“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.”
Impella Heart Pumps Linked to Deadly Heart Injuries
Patients can suffer severe, life-threatening heart injuries or death when the Impella Heart Pump catheter punctures their heart during the implantation procedure, according to the FDA: “Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”
What Is The Risk?
The use of an Impella Heart Pump has been linked to serious risks, including:
- Heart perforations
- Punctured left ventricle
- Hole in the heart
- Emergency surgery
- Hemorrhaging
- Internal bleeding
- Free wall rupture of the left ventricle
- Lack of blood-flow
- Death
Do I Have a Heart Pump Lawsuit?
The Schmidt Firm, PLLC is currently accepting Impella Heart Pump induced injury cases in all 50 states. If you or somebody you know was injured by an Abiomed Impella Left-Sided Blood Pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
