Abiomed Recalls Impella Heart Pumps

Abiomed is recalling (Class 1) Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps to update their use instructions due to a risk that the tip of guidewires or other medical devices may come into contact with the pump during insertion, adjustment, or removal. The inadvertent contact “may result in optical sensor damage, temporary pump stop, or permanent pump stop,” a recall notice says, adding that this may trigger alarms and cause a loss of certain heart and blood pressure readings. To date, no injuries related to the issue have been reported.

The heart pumps are intended to be used for up to 14 days in patients that develop acute right heart failure after left ventricular assist device implantation, Abiomed says. 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.