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The FDA has announced Abiomed has initiated a recall of all left-sided Impella pumps, citing inadequate instructions for use as it pertains to precautions to take with patients who have undergone TAVR.
The US Food and Drug Administration (FDA) has announced a Class 1 recall of all Impella left-sided blood pumps for risk of motor damage after contact with transcatheter aortic valve replacement (TAVR) stent after more than 30 complaints, including 4 deaths related to the issue.
According to the statement released by the FDA, the recall was launched by Abiomed because the pumps’ Instruction for Use do not adequately address precautions to take when treating patients who have undergone TAVR. The FDA, which underlined the product is not being removed from the field and does not need to be returned, warns of potential damage to the motor’s impeller blades if an Impella interacts with TAVR, which the company warns could result in pump failure.1
“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. 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,” reads the FDA statement.1
Since the FDA’s first approval of an Impella device in 2008, the class of devices have undergone an explosion in popularity with more than 50,000 devices implanted in the US during the decade following initial approval.2
The recall, which Abiomed initiated on June 14, 2023, includes the following products and product codes:1
In total, the recall includes 7895 devices in the US distributed from May 1, 2021, to present, according to the FDA. In their statement, the FDA underlined clinicians may continue to use the devices with the additional instructions for patients with TAVR in mind.1
In their June 14, 2023, Urgent Medical Device Correction notice, Abiomed provided recommendations for both clinicians and patients. For clinicians, these recommendations included having awareness of this potential interaction between the Impella system and TAVR, avoiding repositioning while the device is spinning, and turning the device to Po during repositioning or any movement that could bring the outlet windows into proximity to the valve stent structures. For patients, these recommendations included reviewing, completing, and returning the business response form to the recall coordinator identified in the notice.1