Automated Impella Controller Warning Issued Due to Potential Cracks During Device Insertion, Removal

Amid ongoing litigation over Impella heart pump fatalities, Abiomed has released at least two additional safety alerts this year concerning the device’s automated controllers.

Abiomed is urging health care facilities and distributors to remove select Impella Heart Pump Controllers from sale and use, due to issues that could potentially lead to serious injuries or death.

The U.S. Food and Drug Administration (FDA) announced an Impella Heart Pump Controller warning on September 23, stating that some devices’ purge retainers may crack and fail due to excessive force being used when they are inserted or removed from the patient.

Impella Heart Pumps are small, temporary devices that are inserted into a patient’s left heart ventricle through a blood vessel usually in the leg. They are often used in patients with severe heart failure or during high-risk cardiac procedures. The heart pump controller acts as the user interface, displaying real-time data and controlling pump function.

The controller’s purge retainer secures the controller to the device, ensuring proper functioning of the heart pump by preventing blood from entering the motor. If the purge retainer cracks during use, therapy interruptions may occur, which could lead to serious injury or death for the patient.

According to the FDA alert, Abiomed has received reports of at least five serious injuries associated with the purge retainer issue. As a result, the company is recommending that all automated Impella controllers with the following product codes and unique device identifiers (UDIs) be removed from sale and use:

• Impella Controller, Packaged, US, with product code 0042-0000-US, and UDI 00813502010022
• Impella Optical Controller, Packaged, US, with product code 0042-0010-US, and UDI 00813502010985
• Optical, AIC, Impella Connect, Pkgd, US, with product code 0042-0040-US, and UDI 00813502011401
• AIC w/Impella Connect for ECP, with product code 1000432, and UDI 00813502013030
• Dbl optical, AIC Impella Connect, Phg US, with product code 1000201, and UDI 00813502010442

Abiomed is warning that cracks and other damage in the purge retainer of these select Automated Impella Controllers can interfere with the device’s pressure system.

This damage often happens when users push too hard while inserting or removing the purge disc. If the retainer fails, it can trigger system errors, alarms or even shut the pump down, cutting off the blood flow support the device provides, which could put patients’ lives at risk.

The company sent a letter to all affected customers on September 16, indicating that current inventories may continue to be used. However, when contacted, device users should work with Abiomed’s field service team to return the affected device for repair.

Repairs will be implemented through the Abiomed Service Center, and will consist of a correction to the purge retainer fixture.

Any adverse events or other problems experienced with these products can be reported to the FDA’s MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088 to request a reporting form, or else downloading the form from www.fda.gov/MedWatch/getforms.htm. Completed forms may be returned to the pre-addressed location provided on the form or via fax at 1-800-FDA-0178.

Impella Heart Pump Recalls

This is at least the third early warning Abiomed’s Impella Heart Pump Controllers have undergone this year. FDA early warnings often precede a device recall, particularly when there is a risk of serious injury or death.

In July, the FDA issued an early warning for certain Impella Heart Pump Controllers, following failures of controllers to detect pumps when connected, increasing the risk of serious injury or death. A second alert was issued last month, after a patient died due to issues with Automated Impella Controllers.

In addition, a recall of Impella RP and Impella RP Flex Heart Pumps with SmartAssist was issued in February, due to the risk of contact between guidewires and other medical instruments, which could cause the heart pump to shut down unexpectedly.

A prior Impella Left Sided Blood Pump recall was issued in March 2023, after heart ventricle perforations linked to the device killed nearly 50 patients and injured about 130 others.

These actions came on the heels of a March 2023 recall of Impella Left Sided Blood Pumps, which were linked to nearly 50 deaths and more than 130 injuries caused by heart ventricle perforations. That was one of three recalls issued for Impella devices in 2023.

Following these recalls, Impella heart pump lawsuits have been filed nationwide, alleging that Abiomed was aware of serious Impella heart pump risks for years but failed to act, placing profits ahead of patient safety.