Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

Abiomed has recalled the labeling for catheters used in its Impella RP Flex with Smart Assist System, the US Food and Drug Administration announced Thursday. The action comes from concern over a lack of clarity on what precautions operators should take if a patient is slow to respond to anticoagulation.

The agency has deemed the action a Class I recall, its most serious type, but specified “this recall is a voluntary correction, not a product removal.” Thus far there have been 12 reported injuries, but no reports of death.

Impella RP with SmartAssist is indicated for use for up to 14 days in patients who develop acute right heart failure after receiving a left ventricular assist device.

“Abiomed is recalling the labeling for Impella RP Flex with Smart Assist System Catheter because the catheters' Instructions for Use (IFU) do not appropriately address precautions for healthcare providers to take when treating patients whose anticoagulation clotting time is below the recommended value,” the FDA alert states. “Patients with central venous lines and cardiac cannulas with systemic anticoagulation below IFU recommendation of 160-180 seconds are most at risk.”

Clinicians can continue to use the actual devices, but should employ extra safeguards because it’s possible that the issue can have consequences including blood clots or particle deposits forming, or death.

Abiomed sent an Important Medical Device Advisory letter on June 29, 2023, that described the appropriate precautions. A total of 65 devices, distributed between November 2022 and the present time, are affected in the United States (model number 1000323). The manufacturer is currently updating the catheter’s IFU to clarify the risk factors for potential thrombus formation or deposition and to offer recommendations.

In a company statement, Abiomed told TCTMD that the Impella RP Flex with SmartAssist is available at 26 US hospitals in a limited market release. “This correction updated the Instructions for Use to provide updated guidance on how to minimize the risk factors for thrombus ingestion,” the statement said. “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.”

Just last month, Abiomed, which was acquired by Johnson & Johnson late last year, issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling didn’t fully address the precautions needed when treating patients who have undergone TAVI. That, too, was categorized by the FDA as a Class I recall.