The FDA has recently taken action by issuing a Class I recall for the miniaturized internal heart pumps developed by Johnson & Johnson’s Abiomed division. These specific pumps, known as Impella devices, are designed as catheter-based pumps to assist weakened heart muscles by reducing their workload. Unfortunately, the recent update from the FDA has revealed a concerning link between the use of these devices and four reported deaths.
The critical issue at hand revolves around the potential collision between the Impella device and a patient’s aortic valve replacement during a procedure called Transcatheter Aortic Valve Replacement (TAVR). The outer stent-like struts of the TAVR implant have the possibility of coming into contact with the Impella pump. This collision can lead to the shearing off of the pump’s spinning blades, which, in turn, causes certain parts of the device to fracture. Abiomed had previously made healthcare providers aware of this problem through a safety notice issued in mid-June.
The consequences of such a collision can be severe and potentially life-threatening. Not only can it result in a dangerous reduction of blood flow through the damaged heart pump, but it may also introduce harmful debris into the patient’s bloodstream. In light of these potential risks, the FDA categorizes this recall as Class I, signifying a high risk of injury or death to patients.
Initially, Abiomed had reported 27 instances of this issue, accounting for approximately 0.7% of all patients who underwent TAVR and were treated with an Impella system since 2016. However, in a recent update, the FDA has raised the number of complaints to 30, including 26 injuries and four fatalities related to this problem.
The recall encompasses almost 7,900 devices that have been distributed in the United States since May 2021. These devices include various models and sizes of Impella pumps designed for use on the left side of the heart during minimally invasive coronary procedures, open-heart surgeries, and the treatment of cardiogenic shock following a heart attack.
One of the key issues identified by the FDA is the lack of sufficient guidance provided to clinicians in the device’s instructions for use document regarding the management of Impella in patients with TAVR implants. As a result, the notice urges surgeons to adhere to the updated instructions and ensure that the pump is not spinning while being repositioned during a procedure.
In response to the situation, both the FDA and Abiomed advise healthcare providers to promptly replace the Impella pump if they observe any signs of low blood flow while treating a patient with a TAVR implant. However, it is noteworthy that the recalled devices do not need to be immediately returned to the manufacturer. Instead, they can still be used with caution as long as clinicians strictly follow the updated instructions.
The FDA’s decision to classify Abiomed’s Impella devices as Class I recall highlights the potential risks associated with their use in patients undergoing TAVR procedures. The collision between the Impella pump and aortic valve replacements poses serious complications, underscoring the need for healthcare providers to exercise heightened vigilance in managing these devices to ensure patient safety. Continuous monitoring and adherence to the revised instructions are crucial to mitigate the risks and safeguard the well-being of patients during these critical medical interventions.