Abiomed Impella Heart Pump Lawsuit
Johnson & Johnson subsidiary, Abiomed has issued a recall for the instructions for use of Impella Heart Pump devices 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
- Death
The FDA has received reports of at least 129 serious injuries and 49 deaths associated with use of the Impella Heart Pump devices.
People or loved ones of those who were injured, experienced complications, or died after implantation of an Impella Heart Pump Device between October 10, 2021 and October 10, 2023 may be eligible for compensation.
Impella Heart Pump Device Recall
The Impella Heart Pump manufactured by medical device-maker, Abiomed, a division of Johnson & Johnson, was subject to an FDA recall in June 2023. The recall affected Impella Blood Pump Devices distributed after May 2021 but involves only the instructions for using the devices.
In July 2023, the FDA classified the recall as Class I, indicating that problems associated with use of the devices could result in serious injury or death. The FDA has continued to focus on instructions and warnings regarding use of the device but has not recalled or removed the device itself from the market.
Impacted Impella heart pumps include:
- 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
Impella Heart Pump Use
The Impella Heart Pump is manufactured by medical device-maker, Abiomed, a division of Johnson & Johnson. It is a tiny medical device which is threaded through blood vessels to maintain circulation in patients who are undergoing complex procedures and in those with life-threatening conditions.
The Impella heart device is intended to be left in place for up to 14 days in patients who suffer acute heart failure in one side of the heart after a heart attack or heart procedure such as heart catheterization, valve replacement, or other surgery.
Risks of Impella Heart Pump Use During Cardiac Procedure
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).
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. Either case may result in serious injury or death.
At least 129 injuries and 49 deaths in the U.S. have been associated with the Impella Heart Pump System. Other injuries and deaths may have also occurred outside of the U.S.
History of Impella Heart Pump Issues
The newest, March 2024 recall of the Impella devices focuses on the risk that the pump catheter may perforate the wall of the left ventricle of the heart. It is the second Class I recall for the same pumps. Physicians and surgeons have been advised to take additional care in using the devices for PCIs.
However, the 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 one recall as Class I, indicating that use of the devices may result in serious injury or death. A second Class I recall has now been issued for the same devices.
Abiomed was also forced to issue a recall for leaky Impella 5.5 heart pumps which was also categorized as Class I.
People or loved ones of those who underwent an Impella Blood Pump procedure and experienced serious injury or who died after an Impella procedure performed between October 10, 2021 and October 10, 2023 may be eligible for compensation.