This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge sidearm of the pump. Last month, the company issued another Impella recall, this time for potential contact with transcatheter aortic valve replacement (TAVR) implants.
The FDA shared a notice labeling the recall as Class I, the most serious kind. It impacts 65 of Abiomed’s Impella RP Flex with SmartAssist devices in the U.S. It’s a voluntary correction — not a product removal.
Abiomed distributed affected devices between Nov. 1, 2022, and now, initiating the recall on June 29, 2023. Clinicians may continue to use devices. However, the use of affected catheters may cause serious adverse health consequences. Those include the risk of blood clots or particle deposits forming or death.
The company recalled the devices because the SmartAssist system catheter’s instructions for use don’t appropriately address certain precautions. FDA said the precautions pertain to healthcare providers treating patients whose anticoagulation clotting time falls below the recommended value.
Patients with central venous lines and cardiac cannulas with systemic anticoagulation below recommendations of 160-180 are most at-risk.
Abiomed received 12 reports of injuries and zero reports of death related to the issue.
The Impella RP Flex with SmartAssist system catheter is used for up to 14 days in patients that develop acute right heart failure after left ventricular assist device implantation. The device is placed via the internal jugular vein and supports the right chamber of the heart (ventricle) by pumping blood into the pulmonary artery.
Directions for affected customers from Abiomed
Abiomed sent all affected customers an important medical device advisory letter on June 29. It recommended that, to minimize the risk of thrombus formation or deposition, users maintain systemic anticoagulation when indwelling central venous lines are present. This should occur for the duration of Impella RP Flex with SmartAssist support as clinically feasible.
The company recommended that users assess the risk for extraluminal thrombus on indwelling lines placed prior to initiation of support. They should refer to the recommendations included in the “best practices pathway” in the instructions for use.
Abiomed said it is revising the instructions for use for the device. Revisions aim to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.
The company issued the following statement to MassDevice via email:
At Abiomed, our first priority is our patients, including the safe and effective use of our products.
On June 29, Abiomed issued a medical device correction to customers about Impella RP Flex with SmartAssist, which is in a limited market release at 26 U.S. hospitals. This correction updated the instructions for use to provide updated guidance on how to minimize the risk factors for thrombus ingestion.
This notification is not a product removal. Impella RP Flex technology remains available and can continue to be used safely in patients in accordance with the instructions for use.
