J&J’s Abiomed Updates Impella RP Instructions in Class I Recall

Johnson & Johnson MedTech’s Abiomed has updated the use instructions for the Impella RP with SmartAssist and Impella RP Flex heart pumps, following the issue of a Class I recall.

The update comes due to a risk that the tip of guidewires or other medical devices can contact the Impella pump during insertion, adjustment, or removal. This interaction can cause optical sensor damage, temporary pump stop, or permanent pump stop, causing an alarm trigger and loss of some heart and blood pressure readings.

There have been no reported injuries or deaths related to this issue at the time of writing. The product is not being removed from the field and doesn’t need to be returned.

Abiomed advised that if any subject products were forwarded to another facility, to contact that facility and give them the Urgent Medical Device Correction notification. Updated instructions for use, found in the Correction notification, should be used when inserting, manipulating, or removing concomitant devices.

The Impella RP Flex with SmartAssist system catheter is used for up to two weeks in patients that develop acute right heart failure after left ventricular assist device (LVAD) implantation. The device is place via the internal jugular vein and supports the right ventricle by pumping blood into the pulmonary artery.