The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling all of its left-sided Impella blood pumps. This is a Class I recall, which means using these devices “may cause serious injuries or death.”
However, the devices do not need to be returned; the recall is in place to make customers more aware of the issue.
Abiomed’s recall includes 7,895 blood pumps distributed from May 2021 to the present day. Exact devices impacted by the recall are the Impella 5.0 Blood Pump, Impella CP Blood Pump, Impella 2.5 Blood Pump, Impella CP with SmartAssist Blood Pump, Impella LD Blood Pump and Impella 5.5 with SmartAssist Blood Pump. Product numbers are available on the FDA’s website.
These devices are being recalled due to potential issues that can occur if they are implanted into a patient who has already undergone transcatheter aortic valve replacement (TAVR). Abiomed said the blood pumps’ instructions “do not adequately address” the precautions that should be taken when treating patients with a history of TAVR, resulting in a risk of the blood pump’s motor interacting with the TAVR valve. Such interactions could damage or even destroy the motor’s blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient,” according to the advisory. “This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream.”
There have been 30 complaints so far about this issue, including 26 injuries and four deaths.
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