Abiomed has voluntarily recalled the labeling for one model of its Impella circulatory assist pumps because it doesn’t “appropriately address” certain safety issues, the US Food and Drug Administration has announced.
The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.
The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.
Twelve related injuries but no deaths have been reported, the agency said.
The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.
However, “The use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.
Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”
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