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 an Urgent Medical Device Recall (Correction) notice to affected customers recommending updated use instructions for all Automated Impella Controllers (AIC). Affected devices:

Product Code	Product Description	UDI-DI
0042-0000-US	Impella Controller, Packaged, US	00813502010022
0042-0010-US	Impella Optical Controller, Packaged, US	00813502010985
0042-0040-US	Optical, AIC, Impella Controller, Pkgd, US	00813502011401

Full List of Affected Product

What to Do

Be aware that a software error may cause the AIC to restart when used in conjunction with left ventricular Impella devices.

On May 14, Abiomed sent all affected customers a letter recommending the following actions:

In the scenario of extended (>80 min) lack of pulsatility (< 12 mmHg), followed by a sudden change in LV pressure an AIC console restart will occur during support levels greater than P-3. Additional hemodynamic support may be required in this hemodynamically compromised population.
If such an episode is encountered, a console exchange is unnecessary as the phenomenon will recur on the exchange device.
In patients additionally supported with veno-arterial ECMO, unloading of the ventricle at a level of support of P-3 or lower will avoid the restart from happening as the LVP calculator causing the issue is off.
Forward Abiomed’s notice to anyone in your facility that needs to be informed and post a copy of the notice in a visible area for awareness.
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 has identified that when a patient is treated with a left ventricular Impella device and experiences an extended period (>80 minutes) with no residual pulsatility (<12 mmHg on the aortic placement signal), the Automated Impella Controller (AIC) may be forced to restart because of an internal software error. This can occur if there is a sudden change in left ventricular (LV) pressure while the left ventricular pressure (LVP) calculation is active (level of support above P-3). Disabling the aortic placement signal and the LVP display does not prevent the AIC from restarting.

During the restart, the AIC screen will turn black without further alert and the pump will stop for a duration of approximately 35 seconds based on preliminary data, during which the patient is unsupported by the Impella system and regurgitation via the cannula may occur. After the AIC restarts, the pump will automatically resume at the previous P-level. Replacement of the AIC with another AIC would not resolve the potential for an AIC restart.

Patients without alternate mechanical support in place could be at increased risk for serious injury or death due to the resulting lack of hemodynamic support in the event of system reboot.

Product is not being removed, and hospital inventory can continue to be used. Abiomed is working on a software update to the AIC to address this issue.

As of April 27, Abiomed has reported two serious injuries and one death 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, or questions about this issue should contact Abiomed at [email protected].

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 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.