This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk 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 all Automated Impella Controllers (AIC) have updated instructions for use:

What to Do

Be aware that an Automated Impella Controller (AIC) may not detect an Impella pump when connected. Have a back-up AIC available in the unlikely event of a device failure.

On June 23, Abiomed sent all affected customers a letter recommending the following actions:
- Have a back-up Automated Impella Controller (AIC) available in the unlikely event of a device failure.
- Console-to-Console Transfer: If the AIC screen in Image 1 remains for more than 20 seconds and does not advance after connecting the pump to the transferred console:
  - Immediately switch the pump to the previous console to restore support to the patient.
  - If the previous console displays an alarm message, switch to a different console if available.
  - Restart the console that does not advance from Image 1 before attempting to re-connect a pump.
- Case Start: If the AIC screen in Image 2 remains for more than 20 seconds after connecting the pump and does not progress to indicate “Detecting Impella”, either re-start the case on the console or switch the pump to a different console
- Review this notice carefully and forward to anyone in your facility that needs to be informed
- If any affected 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 they have identified an Automated Impella Controller (AIC) issue that may impair the detection of an Impella pump when connected to an AIC. The pump detection issue may occur with any of the Abiomed Impella pumps and may occur during console-to-console transfer or case start. There is no visual alarm displayed on the AIC screen to indicate the detection issue in these situations.

This issue may result in inadequate hemodynamic support. Patients in cardiogenic shock are at increased risk, as prolonged episodes of inadequate support may not be well tolerated and may lead to life-threatening injuries.

As of June 13, Abiomed has reported no serious injuries and 3 deaths associated with this issue.

Device Use

The Automated Impella Controller is the primary user control interface for the Impella Catheter. The Impella pump system is a blood pump that provides temporary full or partial heart support. The device pumps part or all of the patient’s blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abiomed at 978-646-1400.

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.