Abiomed Impella Blood Pump Recall – Class Action Investigation

CSK&D is investigating a potential class action lawsuit against Johnson and Johnson subsidiary Abiomed Inc. related to an alleged safety defect found in Impella Heart Blood Pumps distributed after May 2021. The devices have been associated with an increased risk of left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. The FDA has received reports of at least 129 serious injuries and 49 deaths associated with use of the Impella Heart Pump devices.

These small devices were primarily designed for short term support of the heart’s pumping chambers, or ventricles, in patients who suffer acute heart failure in one side of the heart after a heart attack or procedures such as catheterization, valve replacement, or other surgery. The Impella’s pump motor housing may become damaged if it comes into contact with the heart stent used for valve replacement. If this occurs, the Impella pump may have reduced blood flow or stop completely. In addition, during implantation, the device catheter may contact the ventricle wall or pieces of the broken Impella system may enter the bloodstream, resulting in heart wall damage or puncture.

Potential risks of Impella Heart Pumps may have been identified as early as January 2018 when Abiomed identified a “rare complication” of heart tears. A bulletin notice regarding the potential issue of Iatrogenic LV Perforation was posted on Abiomed website in October 2021. FDA personnel have stated that the company should have notified the Agency within 10 days regarding the warning but failed to do so.

The device was not recalled until June 2023, after the FDA had received 30 event reports including 26 injuries and 4 deaths. In July 2023, the FDA categorized it as a Class I recall, indicating that use of the devices may result in serious injury or death. The recall impacted the Impella heart pumps listed below, but only involved the warnings and instructions for using the devices and did not remove the device from the market.

Impella 2.5 Intravascular Micro Axial Blood Pump

Impella CP Intravascular Micro Axial Blood Pump

Impella CP with SmartAssist Intravascular Micro Axial Blood Pump

Impella 5.0 Intravascular Micro Axial Blood Pump

Impella 5.5 with SmartAssist Intravascular Micro Axial Blood Pump

Impella LD Intravascular Micro Axial Blood Pump

In March 2024, the FDA issued a second Class I recall of the same Impella heart pumps due to the risk that the pump catheter may perforate the wall of the left ventricle of the heart, including that this problem could result in serious injury and death. Physicians and surgeons have been advised to take additional care and consideration in use of Impella in certain cardiac procedures, mainly those involving percutaneous coronary interventions (PCI).

Hospitals and other healthcare facilities that purchased these devices are being asked to adhere to new and revised warnings associated with use of these devices. Abiomed has not advised hospitals or medical facilities using these devices to discontinue use of these devices altogether. Rather, the onus is placed on medical facilities to ensure that their staff is well-informed of the new revised warning that they will all need to follow to avoid the perforation risk associated with these machines.

If you, or a loved one, were injured, experienced complications, or death, after implantation of an Impella Heart Pump, or if you are a hospital, medical practice, or ambulance company that owns one of the products affected by the recall, please contact us by filling out the form below.