During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.

The U.S. FDA reported July 11 a class I recall for patient return electrodes used during electrosurgical procedures that may burn the patient with sufficient severity to induce a third-degree burn. More than 21,000 of the electrodes, made by Raritan, N.J.-based Ethicon Inc.’s Megadyne division, are subject to the recall, although the agency said the manufacturer is still conducting a root cause analysis of the issue.

The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.