Johnson & Johnson’s Abiomed is advising customers to remove certain automated controllers for its Impella heart pumps from where they are used or sold after one death was linked to an issue with the devices, the Food and Drug Administration said Wednesday.
The automated Impella controllers recommended for removal have a pump driver circuit assembly that does not meet current specifications, according to the FDA’s early alert.
The assemblies contain 25v-rated tantalum capacitors instead of 35v-rated tantalum capacitors. The difference may lead to decreased pump performance or the pump stopping and triggering an “Impella Failure" or “Impella Stopped. Controller Failure” alarm, with the potential for loss of circulatory support or death, the FDA said.
As of Aug. 12, Abiomed reported one death and no serious injuries associated with the problem. The FDA communicated the information as part of its pilot program for providing early alerts about potentially high-risk issues.
Abiomed sent an Aug. 20 letter to all affected customers recommending they quarantine and do not use the products. Customers were advised to contact the company to initiate a remediation process.
“Johnson & Johnson MedTech is initiating a voluntary recall (removal) of 69 Automated Impella Controllers (AIC) after identifying a capacitor failure that, in rare cases, may lead to decreased pump performance or pump stop,” a J&J spokesperson said in a statement emailed to MedTech Dive.
J&J said a review of complaints from January 2011 to June 2025 showed a 0.006% occurrence rate, with one complaint reporting a patient death.
The company will provide loaner automated Impella controllers for customer use, the spokesperson added.
Abiomed’s Impella heart pumps are used to reduce the work of the heart's left ventricle and provide support for the circulatory system to allow the heart time to recover.
J&J acquired Abiomed for $16.6 billion in 2022. Since then, Abiomed has recalled multiple products and received a warning letter in September 2023 due to issues with Impella.
In June, Abiomed notified customers of a separate problem with automated Impella controllers that was linked to three deaths.
