Impella Catheter Introducer Kit Warning Issued Over Blood Clot Formations: FDA

Warning adds to a series of FDA recalls and safety alerts involving Impella heart pump systems, which have been linked to device failures that may interrupt treatment and cause a sudden loss of circulatory support.

Federal regulators have issued an early alert for certain Abiomed catheter introducer kits used with Impella heart pumps, after reports of blood clot formation led to at least three serious injuries.

A catheter introducer kit is a medical device used to create and maintain access to a blood vessel so that a catheter or other device can be inserted into the body. The affected Abiomed introducer kits are specifically designed to introduce the Impella heart pump into a patient’s left ventricle.

Impella heart pumps are small catheter-based heart pumps that are used to maintain blood flow in patients suffering cardiogenic shock or undergoing certain high-risk cardiac procedures. 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.

In the affected catheter introducer kits for Impella devices, clots may form within the introducer sheath during prolonged use, potentially disrupting blood flow. If a clot becomes dislodged, it can block blood vessels and cause ischemia.

Ischemia occurs when the blood supply is restricted to a part of the body, depriving tissues of oxygen and nutrients. It requires urgent medical intervention, and in rare cases may result in permanent injury if not promptly corrected.

Impella Catheter Introducer Kit Alert

Customers affected by the recall were notified by letter on May 22 and instructed to review their inventory for impacted kits, quarantine those products for return to Sedgwick, and notify anyone who manages, transports or stores the compromised devices.

The FDA is advising providers not to use the following products:

• 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP, product code 1000434, UDI 00813502012996 
• 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP, product code 1000435, UDI 00813502013009 
• Impella CP Set with SmartAssist (10th Generation), product code 1000413, UDI 00813502013566 

Consumers in the U.S. who have experienced adverse reactions, quality issues, or have questions about the recall may contact Abiomed at OneMD-Field-Actions@its.jnj.com.

Adverse reactions or quality problems can also be reported to the FDA’s safety information and adverse event reporting program, MedWatch.

Impella Heart Pump Recalls

The new warning over catheter introducer kits for Impella heart pumps adds to a growing number of FDA recalls and safety communications involving the Abiomed systems. These alerts have repeatedly raised concerns about device failures that may interrupt treatment or cause a sudden loss of circulatory support.

Federal regulators issued a warning last week involving certain Impella CP Sets with SmartAssist, following at least three reports of device failures as a result of low purge pressure events that resulted in at least one death.

The prior week, Abiomed also warned that a software defect affecting Automated Impella Controllers (AICs) could cause the devices to unexpectedly reboot during use, potentially disrupting blood flow support for critically ill patients. The FDA indicated that the problem had already been linked to two serious injuries and one death.

In 2023, a recall involving Impella 5.5 with SmartAssist devices warned that purge fluid leaks could increase the risk of pump malfunctions, heart valve damage and other serious complications, with regulators citing at least 179 adverse event reports.

That same year, the FDA issued a Class I recall for Impella Left Sided Blood Pumps after receiving reports linking the devices to perforations of the heart wall, a problem associated with at least 129 injuries and 49 deaths.

Federal regulators also announced a Class I recall for Impella RP Flex catheter systems in June 2023, warning that inadequate instructions regarding blood clot risks could expose patients to severe or potentially fatal complications. At the time, the FDA said the issue had been tied to at least 12 reported injuries.

Impella Heart Pump Lawsuits

Impella heart pump lawyers are investigating potential Impella heart pump lawsuits on behalf of patients and families affected by severe complications allegedly associated with the devices, including:

Individuals who experienced serious injuries or lost a loved one following treatment with an Impella heart pump may be eligible to pursue compensation through a product liability lawsuit. Case evaluations are free and confidential, and no legal fees are charged unless compensation is recovered.

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