Temporary Non-roller Type Right Heart Support Blood Pump

Impella RP with SmartAssist. Product Code: 0046-0035.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Impella RP Flex with SmartAssist. Product Code: 1000323.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Impella RP. Product Code: 0046-0011.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Impella RP with SmartAssist; Product Number: 0046-0035;

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

Impella RP Flex with SmartAssist; Product Number: 1000323;

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis