After 49 deaths, the FDA has identified a recall for the use instructions for Abiomed’s Impella left-sided heart pumps as Class I, the most serious type of recall.

The Impella pumps are intended for short-term implantation to assist heart function as the muscle recovers from injury or illness. According to the FDA, the pump catheter may perforate the left ventricular wall during operation. This can lead to wall rupture, hypertension, lack of blood flow, and death.

The Abiomed instruction recall, which the company instituted on Dec. 27, 2023, affects 66,390 devices distributed over two years. These devices have been associated with 129 reported serious injuries, including the 49 reports of death. The notification is not a device removal and the Impella heart pumps remain on the market, the company said.

Read the Abiomed recall notice here.

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