The FDA alerted customers to a letter from J&J MedTech‘s Abiomed, instructing them to remove certain Automated Impella Controllers (AICs) from use or sale.
This communication comes as part of the FDA’s Communications Pilot to Enhance the Medical Device Recall Program. The agency said it became aware of a potentially high-risk device issue.
According to an Abiomed spokesperson, the issue affects 69 AICs globally.
Abiomed told customers not to use affected Impella controller products and quarantine all affected devices. In an Aug. 20 letter, the company said customers should contact its field service team to initiate the remediation process.
According to the FDA notice, Abiomed says that certain controllers have a pump driver circuit assembly that fails to meet current specifications. These assemblies contain 25v-rated tantalum capacitors instead of 35v-rated tantalum capacitors. This may lead to decreased pump performance or pump stop, triggering an “Impella Failure” or “Impella Stopped. Controller Failure.” alarm.
In the case of a capacitor failure in the controller, an abrupt pump stoppage or decreased performance may occur. This can result in transient hemodynamic instability, loss of circulatory support or death.
As of Aug. 12, 2025, Abiomed reports one death and no serious injuries associated with the issue.
This warning comes not long after a different FDA early communication related to the Impella pump controllers. In July, the FDA alerted providers that Abiomed issued updated instructions for use related to all of its Automated Impella Controllers (AICs). As of June 13, Abiomed had reported no serious injuries and 3 deaths associated with that issue.
An Abiomed spokesperson issued the following statement to MassDevice via email:
“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 review of complaints from January 2011 to June 2025 showed a 0.006% occurrence rate, with one complaint reporting a patient death.
“Our first priority is our patients, and we are deeply committed to ensuring the safety and quality of our technologies. We notified impacted customers starting Aug. 21, 2025 and will provide loaner AICs for customer use.”
Table of affected Abiomed products:
|
Product Code(s) |
Product Description(s) |
UDI-DI(s) |
|---|---|---|
|
0042-0000-US |
Impella Controller, Packaged, US |
00813502010022 |
|
0042-0000-UK |
Impella Controller, Packaged, UK |
00813502011296 |
|
0042-0000-CA |
Impella Controller, Packaged, CA |
00813502011272 |
