Impella CP Heart Pump Recall Issued For Devices Shipped After Failing Inspections

AbioMed has issued several Impella Heart Pump recalls in recent years over the potential for the devices to cause heart wall tears and life-threatening bleeding events, among other injuries.

Federal health officials have issued a recall for Impella Heart Pumps due to the risk of the devices releasing harmful particulate matter or unexpectedly failing during critical lifesaving procedures.

The Abiomed Impella pump is a cardiac support device designed to assist patients with severe heart conditions. The minimally invasive system involves inserting a pencil-sized pump into the heart’s left ventricle via the femoral artery.

Once in place, the Impella pump aids in circulating oxygen-rich blood throughout the body by drawing blood from the left ventricle and expelling it into the ascending aorta. It is primarily used during complex cardiac procedures and in treating conditions like cardiogenic shock, where the heart fails to pump sufficient amounts of blood.

Impella Heart Pump Problems and Recalls

While Abiomed’s Impella pumps have been widely adopted by cardiologists and hospitals for treatment of patients with severe heart conditions since 2008, the devices have been linked to over 100 injuries and fatalities that have prompted FDA recalls and warnings, raising concerns over whether Impella heart pump side effects were fully disclosed.

In August 2023, Abiomed initiated an Impella pump catheter recall due to blood clot risks that were not properly addressed in the devices’ instructions for use. This recall was focused on the catheter system’s instructions and labeling inadequacies, following at least 12 reported injuries.

Earlier this year in March, the FDA issued a Class I recall for the Impella Left Sided Blood Pump after it was found that the pump catheters could pierce the wall of the left ventricle, potentially causing serious and life-threatening effects. At the time of the recall, the manufacturer identified at least 129 serious injuries and 49 deaths linked to these heart perforations.

Shortly after the recall was issued, a study was published in The New England Journal of Medicine in early April, finding 24% of patients using the Impella pump experienced severe bleeding events, reduced blood flow to limbs, hemolysis (breakdown of red blood cells), device failures, or worsening aortic regurgitation, which is the backward flow of blood through a leaky aortic valve.

August 2024 Impella Heart Pump Recall

The latest Impella Heart Pump recall was announced by the U.S. Food and Drug Administration (FDA) on August 12, 2024, warning that the manufacturer identified nine pumps in a single lot that failed inspection, but were inadvertently released to customers.

AbioMed has reported that the recalled Impella CP with Smart Assist Pumps are at risk of releasing harmful particulates or stopping suddenly, which could lead to severe health issues or death, including heart and blood vessel (cardiovascular) complications such as stroke, low blood pressure, damage to red blood cells (hemolysis), bleeding, fluid buildup in the pericardial sac (cardiac tamponade), heart attack (myocardial infarction), the need for additional surgical procedures, or death.

The recalled devices include Abiomed Impella CP with SmartAssist that are equipped with Lot number 1798046 and any of the following serial numbers; 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.

AbioMed first issued an Urgent Voluntary Medical Device Recall (Removal) notice on May 31, 2024, warning customers of the Heart Pump problems and instructing them to examine inventory and immediately quarantine recalled devices.

While AbioMed has indicated that all affected devices have been returned to the manufacturer before reaching patients, the FDA has classified the recall as a Class I recall, indicating that the use of the medical devices could result in serious injuries or death.

Impella Heart Pump Recall Lawsuits

Given the growing number Impella Heart Pump recalls in recent months that have resulted in serious injuries and fatalities, lawyers are now investigating Impella heart pump lawsuits.

Lawsuits are being investigated due to the manufacturer’s potential failure to disclose known adverse events, which could have prevented patients and doctors from making fully informed decisions about the safety of the pumps, potentially leading to additional injuries and deaths.

Financial compensation may be available through an Impella heart pump settlement for individuals who suffered any of the following complications after receiving the heart pump;

• Heart tear/perforation
• Stroke
• Organ failure
• Wrongful death
• Anemia
• Blood clots
• Hypertension
• Bleeding events
• Prolapsed valve
• Vascular damage
• Reduced blood flow
• Hemolysis (Red blood cell destruction)
• Other serious injury