The FDA announced a critical recall on the Impella heart pump. The recall notes a serious risks of injury or death from potential damage to the heart. KBA continues to pursue claims on behalf of people who died after using an Impella heart pump or other Impella heart pump related issues.

Impella Heart Pump Models

The Impella pump is a medical device. It helps pump blood when a patient’s heart is un or less able to do so. The Impella recall applies to models like Impella 2.5, Impella CP, and several others. It concerns over 66,000 devices shipped across the U.S. from October 2021 to October 2023.

Impella Heart Pump Use and Risks

Doctors use these devices during heart surgeries. They also function during  emergencies like severe heart attacks. The issue here is that they may possibly break the heart’s inner wall, which could be deadly.

FDA Impella Heart Pump Recall Details about the Dangers

The Impella recall discussed here concerns a serious risk of injury. The Impella hearth pumps might cut the left side of the heart. This may lead to severe complications such as heart rupture, high blood pressure, stopped blood flow, and even death.

There have already been 129 serious injuries and 49 deaths linked to these problems.

Instructions for Healthcare Teams

Abiomed, the Impella pump manufacturer, sent out urgent instructions on December 27, 2023 to hospitals and clinics using these pumps. The Abiomed Impella recall updates the instructions to assure healthcare providers use special imaging to place the pumps safely, be extra careful with high-risk patients, and make sure everyone handling these devices knows about the new safety guidelines.

Suggestions for Impella Heart Pump Patients

We cannot provide medical advice. Patients should speak with their physicians. We note however that the Impella recall directs people to speak with doctor about what this recall means for you. It’s important to know the risks and discuss other possible options.

This Impella recall is a reminder of the need for careful checks on medical devices to keep patients safe. Everyone using these devices should follow the recall steps closely and keep up with any new information from Abiomed and the FDA.

Not the Impella RP Recall

Note, the Impella recall discussed here is about perforations. This is a different Impella pump recall than the Impella RP recall that came later. For informaiton about the Impella RP recall, see here.

Impella RP Recall

Contact KBA Attorneys about Your Impella

If you or a loved one were impacted by the Impella heart recall, please contact us today. 855-KBA-LAWS (522-5297).