Urgent Recall for Abiomed Heart Pumps

Abiomed has issued an Urgent Medical Device Correction updating the instructions for its Impella RP with SmartAssist and also its Impella RP Flex with SmartAssist heart pumps.

The US Food and Drug Administration has identified this recall as the most serious type, which can cause serious injury or death if the updated instructions are not followed.

However, there currently have been no reported harms, and the devices are not being removed from the field and do not need to be returned. 

The risk is that the tips of guidewires or other medical devices such as central venous lines may touch the Impella pump during insertion, adjustment, or removal. This can result in optical sensor damage, temporary pump stop, or permanent pump stop, which may trigger alarms and cause a loss of certain heart and blood pressure readings.

Investigations to date have not identified product design or manufacturing issues contributing to these events.

Lower the Pump Flow Level

The new instructions recommend that users lower the pump flow level to P-2 and use imaging guidance when inserting, manipulating, or removing any guidewires, indwelling venous lines, or devices to reduce the potential for interactions between the device tip and the pump inlet.

After the procedure is complete, users can return to the previous P-level.

If the optical sensor is damaged, no additional action is required. Hemodynamic support and Impella position are not affected and can be monitored as part of routine patient and pump management, and calculated flow and suction are also unaffected.

In the event of a pump stop, users should follow the displayed prompts of the Impella stopped alarm. Damage to the guidewire or other devices should be evaluated to determine whether a new device is required.