Early Alert: Heart Pump Issue from Abiomed

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 CP Sets with SmartAssist be removed from where they are used or sold.

Affected devices:

Product Description: Impella CP Set with SmartAssist
Product Code: 0048-0003
UDI-DI: 00813502012279
Impacted Serial Numbers: 613525, 644314, 645428, 644591, 672986, 673252, 677223

What to Do

Do not use affected products. Review inventory for affected serial numbers and return to Sedgwick.

On May 18, Abiomed sent affected customers a letter recommending the following actions:

Review all Impella CP Sets within inventory and quarantine any affected sets.
Return affected product to Sedgwick.
Share this information with anyone in your facility who manages, transports, stores, stocks, or uses these devices.
Post a copy of the 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 stated that specific distributed units of Impella CP with SmartAssist do not meet design specifications. This out-of-specification may result in low purge pressure events from the onset of the case.

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.

As of May 7, Abiomed has reported three pump exchanges, which have the potential to result in serious injuries and one death associated with this issue.

Device Use

The Impella CP with SmartAssist Catheter is indicated for providing temporary ventricular support during elective or urgent high risk percutaneous coronary interventions (PCI) performed in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option.

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.