The FDA’s Key MedTech Recalls and Safety Actions in 2024

In a substantial shift for the medtech industry, 2024 has been marked by enhanced scrutiny of medical device recalls by regulators and oversight bodies. Notably, the U.S. Food and Drug Administration (FDA) intensified efforts to expedite public notifications about high-risk recalls. This comes on the heels of the Philips respiratory device recall, one of the largest in history, which prompted a review of the FDA’s recall process by the U.S. Government Accountability Office.

Throughout 2024, several heart devices, including Abiomed’s Impella heart pumps and Abbott’s Heartmate devices, were heavily scrutinized. The latter remain the only left ventricular assist systems on the market, as competitor Medtronic exited the space. Additionally, widespread quality concerns over plastic syringes have led to import bans on four manufacturers, with multiple recalls issued. High-profile product recalls include Hologic’s Biozorb devices, Megadyne’s electrode pads, and Exactech’s shoulder implants due to adverse events and packaging issues. As the industry’s watchdog, the FDA seeks to streamline communication with its newly implemented Center for Devices and Radiological Health’s pilot program.

The medtech industry in 2024 has faced significant recall challenges, underscoring the need for improved safety protocols and communication strategies. The FDA’s initiatives aim to enhance patient protection and trust within the sector. As regulators and companies strive for better oversight, the ongoing adjustments will likely shape future industry practices significantly.

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