The FDA has issued an early alert warning of a potentially high-risk issue affecting certain Abiomed heart pumps.
The agency said Abiomed issued an urgent medical device correction Jan. 27 for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices after identifying a potential malfunction in the differential pressure sensor. The issue may cause the automated controller to display inaccurate information, including pump flow readings and placement signals.
The FDA said the issue has resulted in clinical interventions such as incorrect P-level adjustments or unnecessary pump exchanges, according to a Feb. 3 agency news release. The agency noted the differential pressure sensor does not affect the device’s ability to provide hemodynamic support.
As of Jan. 15, Abiomed reported 22 serious injuries and no deaths associated with the issue.
Abiomed sent a letter to affected customers recommending clinicians rely on P-level flow rates listed in the instructions for use rather than controller display values, verify device positioning with imaging and monitor patient hemodynamics using approved diagnostic devices.
The Impella RP with SmartAssist and Impella RP Flex with SmartAssist are temporary heart pumps used to provide right heart support in patients with acute right heart failure.
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