FDA Issues Early Alert For Johnson & Johnson's Abiomed Heart Pump Controllers

Johnson & Johnson’s JNJ Abiomed has issued an Early Alert regarding its Automated Impella Controllers (AIC) for Impella heart pumps, a device crucial for patients with severe heart conditions. This alert, issued by the Food and Drug Administration (FDA), highlights a critical safety concern following reports of three deaths.

What happened?

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC).

Abiomed identified an issue where the AIC may fail to detect an Impella pump when connected. This pump detection issue can occur during console-to-console transfer or at the start of a case. Critically, the AIC screen does not display a visual alarm to indicate this detection problem.

Also Read: Johnson & Johnson’s Abiomed Unit Recalls Instructions For Some Impella Blood Pumps Due To Cutting Risks

Abiomed has advised users to be vigilant for specific signs. If the screen freezes for more than 20 seconds after connecting the pump to a transferred console and doesn’t advance, users should immediately switch the pump back to the original console to support the patient. However, if the original console shows an alarm, users should switch to a different console instead. Another potential problem occurs at the beginning of a procedure when the screen freezes while showing connection information; if the screen doesn’t advance to “Detecting Impella” after 20 seconds, users are advised to move the pump to a different console.

To mitigate risks, Abiomed recommends keeping a backup controller readily available. The company has stated that device failure itself is unlikely. While the FDA has not yet classified this as a formal recall (e.g., Class I, II, or III), it has issued an Early Alert, which is typically used for issues that could pose serious risks.

Why It Matters?

The Automated Impella Controller serves as the primary user interface for the Impella Catheter, which is part of a blood pump system providing temporary full or partial heart support.

This system helps patients maintain hemodynamic stability during adjunctive procedures or temporarily unloads the heart to aid recovery from acute conditions.

The identified issue with the AIC, the failure to detect the pump, can lead to inadequate hemodynamic support. This poses a significant risk, particularly for patients in cardiogenic shock, as prolonged periods of insufficient support can be life-threatening.

As of June 13, Abiomed has reported no serious injuries and three deaths associated with this issue. 

Previous Class I Recall

It is important to note that this is not Abiomed’s first safety concern regarding its Impella devices. Previous issues include perforation risks with the Impella catheter itself (which was classified as a Class I recall by the FDA in March 2024, linked to 49 deaths and 129 serious injuries) and problems with purge fluid leaks.

Johnson & Johnson acquired Abiomed in 2022. These repeated alerts and recalls highlight the inherent complexities and risks associated with highly advanced, life-supporting medical devices, and the ongoing need for vigilant monitoring and improvements by both manufacturers and regulatory bodies.

Price Action: JNJ stock is trading lower by 0.18% to $155.73 at last check Monday.

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