Impella Left Sided Blood Pump Recall Issued Over Risk of Perforations Due to Faulty Instructions

Abiomed is recalling instructions used for its Impella Left Sided Blood Pumps, due to risk of heart perforation risks, which may have resulted in more than 100 injuries and nearly 50 deaths.

The U.S. Food and Drug Administration announced the Impella Left Sided Blood Pump recall correction on March 21, following numerous reports of the pump catheters piercing the wall of the left ventricle in the heart, which may cause serious and life-threatening health effects.

Impella Left Sided Blood Pumps are used to keep blood pumping through the heart during percutaneous coronary interventions (PCI). They are also used when a patient has recently undergone a severe heart attack, open-heart surgery, or heart failure doe to cardiomyopathy.

As a result of problems with the prior blood pump instructions, the manufacturer reports that there have been at least 129 reports of serious injuries, including 49 reports of death.

Abiomed Heart Pump Catheter Recall Problems 

Abiomed initially announced that it was changing the instructions for the Impella 5.5 with Smart Assist in June 2023, following complaints that the pumps may leak purge fluid, resulting in the risk of device failure.

Following the initial notice, a device correction was issued, indicating that the instructions for use (IFU) failed to warn doctors to be careful when treating patients who have undergone a TAVR procedure. This means doctors could inadvertently cause the Impella motor housing to come in contact with the implanted heart valves, resulting in damage or destruction of the motor blades.

Continuing into August of 2023, Abiomed issued another recall on the Impella pump catheter following at least 12 injuries reported in relation to the catheter system’s instructions and labeling. As a result, the FDA has given the instruction recall a Class I designation, meaning the agency considers problems with the blood pumps to carry a serious risk of injury and death for patients.

Abiomed Blood Pump Recall

The recall affects approximately 66,390 pumps with the following product names: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD. These pumps were distributed nationwide from October 10, 2021, through October 10, 2023.

Abiomed issued an Urgent Medical Device Correction Letter on December 27, 2023, warning customers to adhere to the new and revised warnings regarding the pumps. The letter advises customers to carefully position the pump during operative procedures, to use imaging when advancing or torquing the pump catheter, to exercise special care when inserting the catheter or during CPR, to review updated warnings in the device’s instructions for use, to notify everyone at their facility of the corrections, and to notify other facilities where the products have been forwarded.

For more information, consumers can contact Abiomed, Inc at 978-646-1400. For any adverse reactions or quality problems consumers can also use the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax.