The FDA issued a notice warning that J&J MedTech‘s Abiomed unit recommended the removal of certain Automated Impella Controllers (AICs).
Abiomed issued a letter to affected customers recommending the removal of certain AICs on Sept. 16. The FDA issued its communication as part of a pilot to enhance its recall program after becoming aware of a potentially high-risk issue.
Impella, a heart pump system, aims to reduce the work of the heart’s left ventricle. It provides support for the circulatory system so the heart has time to recover. The AIC serves as the primary user control interface for Impella catheters, controlling them and monitoring them for alarms.
According to the FDA, Abiomed identified AIC purge pressure issues due to purge retainer failures, such as cracks. The company determined that the force users apply during purge disc insertion/removal contributes to the purge retainer failures. Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms and potential interruptions in hemodynamic support when the AIC may need to be replaced.
The FDA notes that purge retainer failures can result in a pump stop with resultant loss of hemodynamic support. Loss of hemodynamic support poses a serious risk to patient health and can lead to permanent impairment or death.
J&J is one of the largest medtech companies in the world. MDO’s Medtech Big 100 Special Report takes a deep look at the world’s 100 largest medical device companies, including J&J. Visit here for a free download.
As of Aug. 27, Abiomed reports five serious injuries and no deaths associated with the issue. The company intends to collect affected products and perform purge retainer updates.
This warning comes not long after different FDA communications related to the Impella pump controllers. In July, the FDA alerted providers that Abiomed issued updated instructions for use related to all of its AICs. As of June 13, Abiomed had reported no serious injuries and 3 deaths associated with that issue.
Last month, the FDA issued another alert for Abiomed instructing customers to remove certain AICs from use or sale. According to an Abiomed spokesperson, the issue affected 69 AICs globally. As of Aug. 12, 2025, Abiomed reported one death and no serious injuries associated with that issue.
Statement from J&J
A spokesperson from J&J shared the following statement with MassDevice via email:
“Johnson & Johnson MedTech is initiating a voluntary recall of a select number of Automated Impella Controllers (AIC) after identifying a necessary design change which requires adding one screw to the purge retainer.
“A review of 660 complaints from February 2022 to July 2024 showed a 0.61% occurrence rate related to a purge retainer failure. The additional screw addresses this issue, and the design change has already been completed in 91% of AICs globally.
“Importantly, this is not a product removal and the AIC can continue to be used. Our first priority is our patients and we have notified the customers with AICs that require updates. ”
Affected devices:
Product Code(s) |
Product Description(s) |
UDI-DI(s) |
|---|---|---|
|
0042-0000-US |
Impella Controller, Packaged, US |
00813502010022 |
|
0042-0010-US |
Impella Optical Controller, Packaged, US |
00813502010985 |
|
0042-0040-US |
Optical, AIC, Impella Connect, Pkgd, US |
00813502011401 |
|
1000432 |
AIC w/Impella Connect for ECP |
00813502013030 |
|
1000201 |
Dbl optical, AIC Impella Connect, Phg US |
00813502010442 |
