Abiomed Impella Recall Issued For Heart Pump Catheter’s Instructions Due to Blood Clot Risks

Abiomed has issued an Impella heart pump catheter recall, due to blood clot risks that were not properly addressed in the devices’ instructions for use.

The U.S. Food and Drug Administration (FDA) announced the Abiomed Impella recall on August 17, indicating that the manufacturer is aware of at least 12 injuries reported in relation to the catheter system’s instructions and labeling. Therefore, the agency has given the recall a Class I designation, meaning it believes the continued use of the products with the current labeling poses a risk of serious injuries or death.

The recalled Impella RP Flex catheter systems are used in hospitals to support patients suffering from right heart failure. The device assists the right chamber of the heart by pumping blood into the pulmonary artery. They are implanted through a patient’s internal jugular vein, and provide circulatory support for a duration of up to 14 days.

According to the recall notice, instruction labels provided with the catheter systems do not provide proper safety precautions or actions health care providers should take if their patient’s anticoagulation clotting rate is below the recommended level. The instructions also fail to indicate the risks of developing blood clots or deposit formations associated with use of the catheters.

Federal regulators warn the lack of clear guidance on the instruction labels can cause serious health consequences for patients if the clinician is unable to take proper precautions or is unaware of the risks involved with using them, which may result in the formation of blood clots, particle deposits, or death.

Abiomed Heart Pump Catheter Recall

The recall impacts approximately 65 Abiomed Impella RP Flex with SmartAssist catheter systems with model number 1000323, distributed in the U.S. since November 1, 2023.

Abiomed issued an urgent medical device advisory letter to consumers on June 29, notifying them of the potential blood clot and deposit formation risks associated with use of the catheters. The manufacturer provided recommendations for clinicians to follow if their patient has a central venous line present before implantation of the catheter system, as well as guidance to refer to for the duration of the patient’s treatment.

The company is currently revising the device’s instructions to clarify the risk factors involved with use of the catheter systems, and to provide updated recommendations for health care providers.

For more information on the recall, customers may contact Abiomed’s clinical support center by phone at 1-800-422-8666.

Aboimed Impella Recall Problems

This is the latest in a series of recent recalls linked to Abiomed Impella systems, and is at least the third recall issued just this summer.

Because of the nature of the devices, these problems are frequently linked to a risk of serious injury or death.

Last month, the FDA announced a Class I designation for an Impella Blood Pump recall, after the manufacturer reported it had received at least 30 complaints, including 26 injuries and four deaths due to the risk of damage to the device’s impeller blades.

In addition, another Abiomed Impella recall was announced in June for devices with Smart Assist technology due to the risk of fuel leaks which could lead to the pump ceasing to function. That recall followed at least 179 complaints and three injuries.

The FDA is encouraging consumers to report any adverse side effects or events to the MedWatch Adverse Event Reporting program using the online reporting form.