FDA Warning Issued Over Impella CP Sets With SmartAssist, After Patient Death

New warning comes amid a series of Impella recalls and safety alerts involving the heart pump devices, which has been linked to cardiac injuries, blood clot complications and patient deaths.

Federal regulators have issued a new Impella heart pump warning involving certain Abiomed Impella CP Sets with SmartAssist, after reports that manufacturing problems may cause low purge pressure events capable of interrupting life-sustaining circulatory support.

The U.S. Food and Drug Administration (FDA) announced the Impella CP early alert on May 27, following three reports of device failures that could have led to serious injuries and resulted in at least one death.

Impella devices are temporary mechanical heart pumps used to maintain blood flow in patients suffering cardiogenic shock or undergoing certain high-risk cardiac procedures. The systems are designed to reduce the workload on the heart while helping stabilize critically ill patients.

However, the devices have been linked to a series of problems in recent years, which have been blamed for causing multiple patient injuries and deaths. These adverse events have prompted a series of recalls and safety alerts by the U.S. Food and Drug Administration.

Impella heart pump lawsuits are now being filed by patients and families who allege that defects with Abiomed Impella heart pumps caused severe injuries or deaths that may have been avoided with stronger warnings or earlier corrective action.

Impella CP Set Warning

According to the FDA, the affected Impella CP Sets may experience persistent low purge pressure alarms, which in some cases could lead to interruption or complete loss of mechanical circulatory support. Regulators warn that sudden loss of support may force emergency pump exchanges, cause hypotension, reduce blood flow to vital organs and increase the risk of death if not rapidly corrected.

The alert specifically involves certain Impella CP with SmartAssist Sets used during elective or urgent high-risk percutaneous coronary intervention procedures in patients with severe coronary artery disease. The affected devices all have product code 0048-0003, unique device identifier (UDI) 00813502012279 and the following serial numbers:

• 613525
• 644314
• 645428
• 644591
• 672986
• 673252
• 677223

Abiomed sent customers an urgent correction notice on May 18, advising hospitals and medical facilities to immediately review inventory and quarantine affected Impella CP Sets. The company instructed customers not to use impacted products and to return the devices through Sedgwick, the recall logistics coordinator.

The FDA also advised healthcare facilities to distribute the warning to all personnel responsible for storing, transporting or using the devices and to prominently post the notice within affected departments.

U.S. customers who experience adverse events, product quality concerns or have questions about the issue are encouraged to contact Abiomed through the company’s email support channel at OneMD-Field-Actions@its.jnj.com.

Healthcare providers and consumers can also submit reports involving adverse events or product quality concerns associated with the devices through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Impella Heart Pump Recalls and Warnings

The new Impella CP Set warning is the latest in a series of FDA recalls and safety alerts involving Abiomed heart pumps, which have raised concerns about device malfunctions, treatment interruptions and sudden loss of circulatory support.

An alert involving Automated Impella Controllers (AICs) was announced by federal regulators last week, warning that a software error could force the controller to unexpectedly restart during treatment, potentially interrupting circulatory support for critically ill patients. Regulators said that issue had already been associated with at least two serious injuries and one death.

Earlier this year, the FDA initiated a recall involving Impella Generation 1 Purge Cassettes after identifying an increased risk of purge leaks that could lead to pump stoppage and sudden loss of hemodynamic support. That issue was linked to at least four serious injuries.

In addition, a 2023 recall affected Impella 5.5 with SmartAssist systems after purge fluid leaks were found to increase the risk of device malfunctions, heart valve damage and other severe complications. The FDA indicated the issue had generated at least 179 adverse event reports.

Earlier that same year, the FDA issued a Class I recall for Impella Left Sided Blood Pumps. The announcement came after reports linked the devices to perforations of the heart wall. Regulators said the problem had already been associated with at least 129 injuries and 49 deaths.

Federal regulators also issued a Class I recall for Impella RP Flex catheter systems in June 2023, cautioning that insufficient instructions regarding blood clot risks could expose patients to potentially fatal injuries. At the time, the agency said the issue had been connected to at least 12 reported injuries.

Impella Heart Pump Lawsuits

Impella heart pump lawyers are investigating potential claims involving patients who suffered severe complications after receiving the heart pump systems, including:

If you or a loved one were injured after receiving an Impella heart pump, submit information about your potential claim for a lawyer to review to determine if you have a claim.

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