Why did the FDA Issue Its Highest Alert for Certain Heart Pumps?

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On March 21, 2024, the US Food and Drug Administration (FDA) classified the recall of Abiomed’s Impella left-sided pumps as a “Class I recall,”  the agency’s “most serious type of recall.” This is a classification the FDA uses when a device imposes a risk of serious injuries or death.

The FDA warned that using these pumps could lead to severe health problems, including high blood pressure, lack of blood flow, and death.

This notice affects 66,390 devices distributed in the US from October 10, 2021, to the present. At the time of the FDA’s action, the heart pump had been linked to 49 deaths and 129 injuries.

This recall is a correction, not a removal, so the device remains available.

Heart Punctures From Incorrect Use of the Pumps

The Impella left-sided pumps are used to temporarily support a patient’s heart during risky procedures or after a severe heart attack. The pump was approved by the FDA in 2008. It has a catheter with a small hook that is threaded through the blood vessels into the left ventricle, a key heart chamber that pumps oxygen-rich blood throughout the body.

However, the FDA warned that if used incorrectly, the pump could puncture a wall in the heart’s left ventricle. The manufacturer, Abiomed, has provided new instructions for the pump.

Abiomed’s Correction Notice

Abiomed first revealed the risk of heart perforation during pump insertion in a technical bulletin. However, the medical device company did not inform the FDA at that time.

The FDA inspected Abiomed’s office in Massachusetts in early 2023 and sent a warning letter in September. The letter criticized Abiomed for not updating the FDA about the heart perforation risk.

The FDA said that Abiomed should have informed the agency over two years ago when the company first posted an update about the perforation risk on its website (October 2021). If Abiomed had done this, the FDA would have issued a wider official warning to hospitals and doctors.

Because of this letter, Abiomed sent out an “Urgent Medical Device Correction” notice late last year. This notice included updated instructions on how to use the heart pump correctly, such as how to position the pump’s catheter and use imaging during procedures.

Who Does the Impella Pump Recall Affect?

According to the FDA, certain types of people could be affected by Abiomed’s Impella left-sided pump recall:

  • People undergoing procedures with Impella Left Sided Blood Pumps
  • People with anterior infarction (heart disease)
  • Elderly people and women

Abiomed’s Promotion of the Heart Pump

According to The New York Times (NYT), several studies have shown that Impella heart devices increase the risk of death in patients with unstable medical conditions. At the same time, the device maker has spent millions of dollars promoting the device, paying cardiologists for consulting, and giving grants to hospitals, NYT reports.

If Your Impella Heart Pump Caused Your Injury, We Can Help

Our medical device lawyers are looking into cases where patients were injured or died after using recalled Abiomed Impella left sided pump. You may be entitled to recover damages, including costs of medical treatment (past and future); as well as lost income; pain and suffering; and other losses.

Contact our office today for a free case evaluation at (800) 277-1193 or fill out the Case Evaluation Form.