FDA: Class I recall of labeling for Impella RP Flex with SmartAssist

Editor's Note

The Food and Drug Administration (FDA), on August 17, identified the recall by Abiomed of the labeling for its Impella RP Flex with Smart Assist System Catheter as Class I, the most serious.

The recall was initiated because the catheters’ instructions for use did not appropriately address precautions when treating patients whose anticoagulation clotting time is below the recommended value.

There have been 12 injuries and no deaths reported.

Clinicians may continue to use the devices. Abiomed is revising the instructions for use to clarify the risk factors and recommendations related to thrombus formation or particle deposition.

Distribution dates were November 1, 2022, to present.