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FDA Announces Major Recall of Impella Heart Pumps for High Injury Risk

  • April 11, 2024
  • KBA Attorneys
  • No Comments

The FDA has declared a critical recall on Impella heart pumps. The recall notes a serious risks of injury or death from potential damage to the heart.

Impella Heart Pump Models

The 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 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 pump manufacturer, on December 27, 2023, sent out urgent instructions to hospitals and clinics using these pumps. They must 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 Patients

We cannot provide medical advice. Patients should speak with their physicians. We note however that the 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 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.

Contact KBA Attorneys

If you or a loved one were impacted by the Impella Heart Pump recall, please contact us today.