The United States Food and Drug Administration (FDA) has issued a Class I Recall, the most serious type of recall for medical devices, for the risk of serious injuries and death in patients.
The March 2024 recall specifically mentions the risk of serious injuries and death in patients due to the potential for the Impella pump catheter to perforate the wall of the left ventricle in the heart, potentially leading to heart perforation, hypertension, lack of blood flow, and in tragic cases, death.
The FDA reported 129 serious injuries and 49 reports of death linked to the Impella Heart Pump devices.
Recalled Impella Heart Pump devices include:
- Impella 2.5
- Impella CP
- Impella CP with SmartAssist
- Impella 5.5 with SmartAssist
- Impella LD
Impella Heart Pump Recalls and Regulatory Action (2023 & 2024)
Impella Heart Pumps are designed by Abiomed, a company acquired by Johnson & Johnson MedTech in late 2022, and have faced significant safety and operational challenges over recent years.
Multiple recalls were placed on Impella Heart Pumps throughout 2023, with an official warning being sent to the manufacturer in October 2023 by the US Food and Drug Administration.
- In June 2023, Abiomed recalled Impella devices due to complications that included leaking purge fluid and adverse interactions with transcatheter aortic valve replacement (TAVR) implants.
- In July 2023, the FDA classified this recall as Class I, indicating that these complications could lead to serious injuries or death.
- This classification came after reports of 30 complaints, 26 injuries, and four deaths directly linked to the devices.
- In October 2023, the FDA sent an official warning letter to Abiomed for failing to report quality problems and for selling its Impella Connect System without FDA authorization or premarket approval.
- The warning letter addressed systemic failures in reporting adverse events and corrections.
The US Food and Drug Administration’s action on Impella Heart Pumps reached a new level of publicity in March 2024, with Abiomed recalling 66,000+ devices and the FDA issuing a Class I Recall.
The 66,390 Impella Left Sided Blood Pumps that were recalled were distributed in the United States between October 2021 and October 2023.
The March 2024 recall is a significant escalation from previous warnings, as it addresses the serious risks of left ventricle perforation—a condition linked to at least 49 deaths and numerous injuries.
The recall was predicated on the device’s potential to cause severe adverse health consequences, including death, due to the catheter’s risk of cutting through the ventricle wall.
Abiomed Updates Patient Safety Instructions
In response to the recall and heightened safety concerns surrounding the Impella Heart Pumps, Abiomed took steps to enhance patient safety through updated instructions and communications.
These measures are aimed at mitigating risks and ensuring the device is used as safely as possible:
- Recalled Instructions for Use: Abiomed recalled the Instructions for Use (IFU) for the Impella devices, including guidance on safe insertion, operation, and continuous monitoring of devices.
- Urgent Medical Device Correction Letters: In a direct communication to healthcare providers in December 2023, Abiomed issued Urgent Medical Device Correction letters. These letters contained critical updates to the device instructions, underscoring the importance of adhering to these new guidelines to prevent adverse patient outcomes.
About the Impella Heart Pumps
The Abiomed Impella Heart Pump is the world’s smallest heart pump, designed to provide temporary support for the heart’s main pumping chamber, the left ventricle, during high-risk medical procedures or in the aftermath of severe heart conditions.
Impella Heart Pumps have been used to treat Acute Myocardial Infarct (AMI) cardiogenic shock.
The device functions by being inserted through a small incision in the leg and guided into the heart, where it helps by directly pumping blood from the left ventricle into the ascending aorta.
This mechanism aids in reducing the workload on the heart by temporarily taking over the pumping function, which is crucial during periods when the native heart is weak or in recovery.
By doing so, the Impella supports the heart’s ability to recover its normal function, offering a vital lifeline for patients undergoing complex cardiac procedures or those in cardiogenic shock following a heart attack.
