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 Impella Purge Cassettes and Impella RP Pump Sets be removed from where they are used or sold.

Affected devices:

What to Do

Identify and remove all Generation 1 Purge Cassettes from use. If a Generation 2 Purge Cassette is not available and the use of a Generation 1 Purge Cassette is absolutely necessary, ensure increased monitoring of the Purge System and refer to the IFU if a “Purge Pressure Low” alarm is triggered.

On February 18, 2026, Abiomed sent all affected customers a letter recommending the following actions:

• Review all Purge Cassettes (both individually packaged and within Impella RP Pump Sets) in inventory and if any Purge Cassettes are identified as impacted, please set aside and quarantine.
• If impacted product is identified, utilize the return shipment label provided by Abiomed to initiate the return.
• Follow your standard process to order Generation 2 Purge Cassettes
  • Use of a Purge Cassette is always required when using an Impella Pump. If a Generation 2 Purge Cassette is not available to you and the use of a Generation 1 Purge Cassette is absolutely necessary, you may continue to use it. However, ensure increased monitoring of the Purge System and refer to the IFU if a “Purge Pressure Low” alarm is triggered.
• Forward this notice 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.
• Post a copy of this notice in a visible area for awareness.

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, Inc. has reported that Generation 1 Purge Cassettes have an increased risk of purge leaks. As a result, Abiomed is removing Generation 1 Purge Cassettes in markets where updated Generation 2 Purge Cassettes are available.

If a Purge Cassette leak were to occur, the user would see a “Purge Pressure Low” alarm on the Automated Impella Controller (AIC); see example of alarm below:

 

A purge leak may lead to low purge pressure if it goes unaddressed. This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.

As of February 3, Abiomed has reported four serious injuries and no deaths associated with this issue.

Device Use

The purge cassette delivers rinsing fluid to the Impella catheter. The purge fluid flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Abiomed at OneMD-Field-Actions@its.jnj.com.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected 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.