FDA Issues Highest-Level Alert for Impella Heart Pump Linked to 49 Deaths

Impella Heart Pump Faces Scrutiny After FDA’s Highest-Level Alert

The U.S. Food and Drug Administration (FDA) has issued its most serious type of recall for the Impella left-sided heart pumps, which are linked to 49 deaths and 129 injuries. The pumps, manufactured by Abiomed, temporarily support a patient’s heart during high-risk procedures or after a severe heart attack.

5 Key Points:

1. The U.S. Food and Drug Administration (FDA) has issued its highest-level alert for the Impella left-sided heart pumps.

2. The pumps have been linked to 49 deaths and 129 injuries due to the risk of puncturing the heart’s left ventricle if misused.

3. The device’s manufacturer, Abiomed, has issued new instructions for the pump’s use.

4. The recall is a correction, not a product removal, and the device will remain on the market.

5. Abiomed first disclosed the risk of heart perforation in October 2021 but failed to update the FDA, leading to a warning letter from the agency.

The FDA warned that the use of affected pumps may cause serious adverse health consequences, including hypertension, lack of blood flow, and death. The agency cautioned that the device could puncture a wall in the heart’s left ventricle if misused.

Recall Details

The recall relates to 66,390 devices distributed in the U.S. over two years, starting from October 10, 2021. However, the FDA clarified that this is a correction, not a product removal, and the device will remain on the market. Abiomed, acquired by Johnson & Johnson in 2022, has issued new pump instructions.

Device Function and Risks

The Impella heart pump has a catheter with a small hook at the end. It is threaded through the blood vessels and into the left ventricle, a critical chamber in the heart used to pump oxygenated blood around the body. The device was given FDA approval in 2008.

Abiomed first disclosed the risk of heart perforation during the pumps’ insertion in a technical bulletin posted in October 2021. However, the company did not share this information with the FDA then.

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FDA Inspection and Warning Letter

The FDA inspected Abiomed’s office in Massachusetts in early 2023 and sent a warning letter to the company in September. The agency criticized Abiomed for failing to update the FDA on the risk of heart perforation, among other issues.

In response to the warning letter, Abiomed issued an “Urgent Medical Device Correction letter” in late 2022, containing revised instructions for using the heart pump correctly. The new guidelines include positioning the pump’s catheter and using imaging when turning it during procedures.

Moving Forward: Ensuring Patient Safety with Revised Instructions

In response to the FDA’s warning letter, Abiomed addressed the risks associated with the Impella heart pump. On December 27, 2023, the company sent all affected customers an Urgent Medical Device Correction letter, providing new and revised warnings for the device’s use (U.S. Food and Drug Administration, 2024). The letter instructed healthcare providers to:

1. Carefully position the pump catheter during operative procedures.
2. Use imaging when advancing or torquing the pump catheter.
3. Use special care when inserting the pump catheter in patients with certain high-risk conditions or during active CPR.
4. Review the updated warnings in the device’s Instructions for Use.
5. Notify everyone at their facility who needs to be informed of this recall correction.
6. Inform any other facilities where the products have been forwarded of the updated Instructions for Use.

By following these revised instructions and adhering to the updated guidelines provided by Abiomed, healthcare providers can minimize the risk of heart perforation and other serious adverse events associated with the Impella heart pump, thereby ensuring patient safety and optimal outcomes.