CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Abiomed has issued a letter to affected customers recommending certain Automated Impella Controllers (AIC) be removed from where they are used or sold. While awaiting service from Abiomed, hospital inventory can continue to be used to ensure continuity of care.
Affected devices:
| Device Name | Product Number | UDI-DI | Serial Numbers |
|---|---|---|---|
| Impella Controller, Packaged, US | 0042-0000-US | 00813502010022 | Limited to Specific Consoles |
| Impella Optical Controller, Packaged, US | 0042-0010-US | 00813502010985 | |
| Optical, AIC, Impella Controller, Packaged US | 0042-0040-US | 00813502011401 |
List of Impacted Serial Numbers
The serial number of the AIC is located on the label on the right side of the device as shown below.
What to Do
While awaiting service from Abiomed, hospital inventory can continue to be used to ensure continuity of care. Various hardware, firmware, and/or software updates are available but have not been implemented consistently across all potentially impacted units. Users should review the recommendations below while waiting to coordinate the scheduling of removal, updates, and return of impacted units with Abiomed.
On September 18, 2026, Abiomed sent all affected customers a letter recommending the following actions:
- Hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care.
- The Abiomed service team will contact you to coordinate the removal, update, and return of the device(s).
- Forward to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products).
- If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Abiomed stated that a retrospective review of servicing records identified certain Impella Controllers that require hardware, firmware, and/or software updates to address quality issues with the potential for safety implications. These quality issues include a potential failure of the AIC to recognize the purge cassette during setup or change; a sticking, unreliable button that could impact the operator’s ability to select and confirm menu entries and possible loss of control of the console; an instability that could result in start-up failure; and other software defects. Without the hardware, firmware, and/or software updates, patients could face various problems such as delay of therapy, inadequate or loss of hemodynamic result, and other serious issues.
As of September 8, 2026, Abiomed has reported no serious injuries or deaths associated with this issue.
Device Use
The Automated Impella Controller is the primary user control interface for the Impella Catheters. It controls the Impella Catheter and monitors the catheter for alarms. Impella therapy aims to reduce the work of the heart and provide support for the circulatory system so the heart has time to recover.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, questions about this issue, or if the Serial Number is missing or illegible, should contact the Abiomed Field Service Team, 1-800-422-8666, option 3, or email ra-abm-fieldaction@its.jnj.com for assistance.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database – Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
