Abiomed faces Class I recall of potentially leaky Impella 5.5 heart pumps

Abiomed has begun a recall of several hundred of its Impella heart pumps after receiving nearly 200 complaints, and the FDA this week gave it a Class I rating, indicating a heightened risk of injury or death.

The Impella devices, billed as “the world’s smallest heart pumps,” are implanted for between a few hours and a few weeks to take over the blood-pumping duties from an ailing heart.

The recall specifically concerns the Impella 5.5 model, which offers full cardiac support for patients experiencing cardiogenic shock linked to cardiomyopathy, myocarditis or a recent open-heart surgery or heart attack. The pump is equipped with Abiomed’s SmartAssist technology, a platform that combines algorithms and optical sensors to give surgeons real-time guidance as they put the implant in place.

The Impella 5.5 system was approved by the FDA in September 2019.

According to its entry in the FDA’s recall database, the Abiomed recall concerns a total of 610 pumps distributed around the world, 466 of which were sold in the U.S., between late September 2021 and early March of this year.

Abiomed began the recall in April. In a letter (PDF) sent to healthcare providers at the time, the company described how in some cases, the purge sidearm of an Impella 5.5 pump may begin to leak purge fluid. It linked the issue to damaged sidearms, including damage to the luer locking mechanism caused by interactions with sodium bicarbonate purge fluid.

“After introducing accessories and communications relaying best practices to mitigate these issues, the complaint rate for purge leak due to sidearm damage has decreased but continues to be higher than devices with the preinstalled retainer and new yellow luer,” Abiomed wrote in the letter. “Currently, product in the field includes units with and without the preinstalled retainer and with or without the new yellow luer components.”

If purge fluid begins to leak and isn’t able to be immediately fixed, it could lead to persistently low purge pressure and flow, which may in turn cause the pump to completely stop working—allowing a patient’s already severe heart condition to worsen.

To date, according to the FDA’s recall notice, Abiomed has received 179 complaints related to the issue, including three reported injuries. The company hasn’t received any reports of patient deaths linked to leaking pumps.

Abiomed said in the letter that it will be replacing all of the recalled pumps that have already been distributed in a phased rollout.

While healthcare providers wait for those replacements, however, the company said they may continue using the affected devices—since “the benefits of using the pump outweigh the risks of pump stop due to purge leaks”—but advised them to follow certain best practices, including examining the pumps before each use, avoiding sterilization solutions containing isopropyl alcohol and connecting an extension tubing set when using sodium bicarbonate purge solution.