Impella Recall Issued Over Guidewire Problems in RP Heart Pump With SmartAssist

Use instructions for certain Impella heart pumps are being updated due to risks of injury or death from guidewires and other medical devices.

Amid growing concerns over fatalities and injuries linked to Impella heart pump devices, AbioMed has issued a recall of its Impella RP and Impella RP Flex Heart Pumps with SmartAssist, warning that the devices may shut down if they come into contact with other medical equipment.

The Impella pump is a small device about the size of a pencil, which is used during open-heart procedures. The device is inserted through the femoral artery in the leg and guided into the heart’s left ventricle. Its purpose is to assist circulation by transferring oxygen-rich blood from the ventricle into the ascending aorta, ensuring a steady blood flow to vital organs during surgery.

Impella Heart Pump Recalls

This new recall comes amid a series of Impella warnings and issues with the heart pumps highlighted by federal regulators in recent years, including concerns of lower-than-expected patient survival rates, heart valve damage and blood clot risks.

In 2023, the U.S. Food and Drug Administration (FDA) announced a Class I recall for Impella Left Sided Blood Pumps, following reports of heart ventricle perforations, which linked the device to 129 injuries and 49 deaths. That same year, another recall was issued for Impella 5.5 with SmartAssist pumps due to purge fluid leaks that led to device malfunctions, heart valve damage and a heightened risk of severe injuries, with 179 related complaints.

Additionally, the FDA issued a Class I recall for Impella RP Flex catheter systems in June 2023, following inadequate safety instructions regarding blood clot risks. This issue was associated with 12 reported injuries and posed a serious risk of death and other complications.

Following these recalls, lawyers throughout the United States have begun evaluating potential Impella heart pump lawsuits on behalf of individuals and families who allege that the manufacturer was aware of Impella heart pump risks for years, but failed to act, placing a desire for profits over patient safety.

2025 Impella Heart Pump Recall

In the latest Impella recall, the FDA announced that AbioMed issued a warning on February 14, updating the device’s instructions for use to reduce the risk of serious injury or death.

In the warning, AbioMed outlines that improper positioning of the Impella heart pump during insertion, repositioning or removal could lead to contact with guidewires or other medical instruments, increasing the risk of device shutdown, serious injury or death.

Contact could damage the device’s optical sensor, stop the pump temporarily, or lead to complete device failure, activating alarms and resulting in the loss of critical heart and blood pressure measurements.

The FDA has categorized the warning issued by the manufacturer as a recall for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices, impacting devices with unique identifier numbers 00813502011869 and 00813502012811.

AbioMed recommends that before customers insert, manipulate, or remove these devices, they consult the updated use instructions, which can be found in the manufacturer’s Urgent Medical Device Correction notice (PDF).

Impella Heart Pump Lawsuits Being Investigated Nationwide

Amid the growing number of Impella recalls issued in recent years, Impella heart pump recall lawyers are investigating cases for individuals who have received the devices and experienced any of the following injuries:

• Heart tear/perforation
• Stroke Organ failure
• Wrongful death
• Anemia
• Blood clots
• Hypertension
• Bleeding events
• Prolapsed valve
• Vascular damage
• Reduced blood flow
• Hemolysis (Red blood cell destruction)
• Other serious injury

Lawyers provide free consultations and claim evaluations to help individuals throughout the United States determine whether financial compensation or settlement benefits through an Impella heart pump lawsuit may be available.