The U.S. Food and Drug Administration (FDA) has issued its most serious type of recall for a widely used heart pump after reports of 49 deaths and 129 injuries associated with the device. The Impella pumps, manufactured by Abiomed, are small mechanical devices designed to temporarily support a patient’s heart during high-risk surgeries or after severe heart attacks.
The FDA’s action, announced on March 21, affects 66,390 devices distributed in the United States over a two-year period beginning October 10, 2021. The recall underscores the critical importance of proper usage of medical devices, as incorrect operation of the Impella pump can pose serious risks, including piercing a wall in the heart’s left ventricle.
The Impella pump received FDA approval in 2008 and works by threading a catheter with a small hook through the blood vessels into the left ventricle—the heart chamber responsible for pumping oxygenated blood throughout the body. While the device provides vital support for patients during critical procedures, the FDA has warned that misuse can lead to severe complications such as hypertension, loss of blood flow, and even death.
In October 2021, Abiomed released a technical bulletin with instructions on the correct use of the pump to prevent damage to the heart wall. However, the FDA discovered during an inspection in early 2023 that the company had failed to submit this crucial information to the agency within the required 10-day period. This oversight led to the FDA issuing a warning letter to Abiomed in September, prompting the company to provide updated usage instructions for the heart pump.
Johnson & Johnson MedTech, which has since integrated Abiomed into its operations, acknowledged the lapse in communication. The company stated that it is implementing broader process improvements as part of the integration into Johnson & Johnson’s quality systems.
The FDA approved new warnings for the device in late December and emphasized its commitment to addressing the issue promptly. “The FDA worked diligently to mitigate this issue after learning about it,” noted FDA spokesperson Audra Harrison.
The recall highlights the global importance of stringent regulatory oversight and adherence to safety protocols in the medical device industry. It serves as a critical reminder for healthcare professionals worldwide, including those in Asia’s rapidly expanding medical markets, to stay informed about device updates and to rigorously follow usage guidelines to ensure patient safety.
