J&J's Abiomed updates labeling for certain Impella heart pumps in Class I safety event

For Abiomed’s beleaguered family of Impella heart pumps, Class I recalls are becoming a monthly event.

The devices have racked up their third recall in as many months, the latest of which focuses on the Impella RP Flex with SmartAssist.

Like its fellow Impella RP pumps, the Flex model is placed in the right side of the heart for up to two weeks to help get blood pumping through the organ and out to the lungs at a normal pace for people with right-sided heart failure. It’s put in place via the internal jugular vein, and Abiomed’s Smart Assist sensors are used to guide that placement and monitor how the device is functioning throughout the use period.

The Impella RP Flex with Smart Assist system was approved by the FDA last fall, and its limited U.S. rollout began in the final months of the year. To date, the system is currently in use in just 26 U.S. hospitals, according to a statement from Abiomed this week.

Johnson & Johnson-owned Abiomed began the devices’ recall at the end of June. Though the FDA proceeded to hand down a Class I rating—denoting a heightened risk of serious injury or death—according to an agency notice Thursday, the safety event isn’t a recall in the traditional sense.

Rather than requesting that a swath of devices be removed from shelves and returned to the company, Abiomed instead began the recall as a voluntary correction, as a way to alert customers to an updated label for the Smart Assist-equipped Impella RP Flex pumps.

Abiomed is correcting the devices’ instructions for use to provide clearer guidance for healthcare providers in situations where a patient’s anticoagulation clotting time is below the recommended level. When those patients are implanted with an Impella RP Flex pump, they’re at risk of blood clot formation or particle deposit buildup, or even death. So far, according to the FDA, 12 injuries have been linked to the recall, with no reported patient deaths.

In the statement sent to Fierce Medtech this week, Abiomed reiterated that the recall “is not a product removal,” noting, “Impella RP Flex technology remains available and can continue to be used safely in patients in accordance with the instructions for use.”

The company added, “At Abiomed, our first priority is our patients, including the safe and effective use of our products.”

The latest safety event comes just a few weeks after the FDA issued an update on the Impella pumps’ previous Class I recall. In that case, several models of Impella devices—though none of the RP models—were found to be at risk of damage in patients who have also been implanted with transcatheter aortic valve replacement (TAVR) devices. At the end of July, shortly after the FDA first classified that recall as Class I, the agency announced that a few more related complaints had since trickled in, including four reports of death.

And a month before that, the regulator hit the heart pumps with yet another Class I recall, this one for about 600 Impella 5.5 pumps that could potentially begin to leak fluid from a damaged purge sidearm. At the time, the company had received 179 complaints linked to the issue, including three reported injuries.