Impella Purge Cassette Removal and RP Sensor Fix Get FDA's Most Serious Recall Rating

The US Food and Drug Administration on April 3 classified two Abiomed actions on its Impella heart pumps as Class I recalls, the agency's most serious type: the removal of first-generation Impella purge cassettes and a correction to use instructions for Impella RP devices with SmartAssist, according to the FDA's updated purge cassette notice and Impella RP notice, both read in their April 2026 versions via the Internet Archive.

Both issues were first published as Early Alerts, on February 25 and February 3 respectively, and the FDA said the affected products and recommendations had not changed with the classification.

Purge cassette leaks

Abiomed has reported that Generation 1 purge cassettes have an increased risk of purge leaks and is removing them in markets where updated Generation 2 cassettes are available, the FDA said. The purge cassette delivers rinsing fluid through the Impella catheter to the microaxial blood pump to keep blood out of the motor. A leak would show as a "Purge Pressure Low" alarm on the Automated Impella Controller.

If unaddressed, a leak may lead to low purge pressure and biomaterial ingress, which may cause an unexpected pump stop, according to the notice; a pump stop may result in loss of hemodynamic support "and lead to patient death." As of February 3, Abiomed had reported four serious injuries and no deaths associated with the issue.

The affected products are the Impella RP US Pump Set and a five-pack of purge cassettes. Abiomed's February 18 letter tells customers to quarantine and return affected cassettes and order Generation 2 replacements. Because a purge cassette is always required to run an Impella pump, the letter says Generation 1 cassettes may still be used when absolutely necessary and no Generation 2 cassette is available, with increased monitoring of the purge system.

Sensor drift in Impella RP

The second action covers all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices, temporary pumps used for right heart support in patients with acute right heart failure. Abiomed identified that the differential pressure sensor in Impella RP devices may malfunction and drift over time, which can cause the controller to display inaccurate pump flow readings and placement signals, the FDA said.

According to the notice, inaccurate displayed information "has resulted in the user making clinical interventions including inaccurate P-level adjustments or unnecessary pump exchanges," though the sensor does not affect the device's ability to provide hemodynamic support. As of January 15, Abiomed had reported 22 serious injuries and no deaths associated with the issue.

Abiomed's January 27 letter tells clinicians to monitor hemodynamics with approved diagnostic devices, verify pump position with imaging before interventions, and rely on the flow rates for each P-level listed in the instructions for use rather than the controller display. This correction does not remove devices from use.