Yet another issue has hit Abiomed’s heart pumps, with the company recalling six products in the Impella range due to insufficient instructions for use in patients with transcatheter aortic valve replacement (TAVR). Abiomed is not pulling the products from shelves or asking for them to be returned, instead issuing a voluntary correction.
The Massachusetts, US-based company, which was acquired in November 2022 by Johnson & Johnson in a $16.6bn deal, initiated the recall after receiving 30 complaints related to the matter. The US Food and Drug Administration (FDA) tagged it as a Class I recall, meaning there is the potential for serious injury or death with continued use of the devices.
Abiomed has sent an Urgent Medical Device Correction notice to customers with proper instructions for patients with TAVR. The company added that the product does not need to be returned.
Abiomed is recalling 7,895 of the devices in the US distributed since May 2021.
As per the FDA alert, Abiomed has reported 26 injuries and four deaths related to the issue.
Dubbed as ‘the world’s smallest heart pump’, the Impella blood pumps are used to maintain blood flow in individuals whose heart isn’t functioning properly, such as patients with cardiogenic shock. The devices are designed to alleviate ventricular workload for short-term use.
Abiomed said that the pumps’ instructions for use do not properly tell clinicians on how to use the Impella devices in patients with TAVR. The result is that certain precautions may not be taken and, if the Impella motor housing touches the distal stent of the TAVR, the system might not stop working due to the motor’s impeller blades breaking. If this happens, not only could patients with the device stop receiving therapy, but broken pieces of the blade could enter the patient’s bloodstream.
The blanket recall comes after Abiomed recalled the Impella 5.5 with SmartAssist System in April. A fault meant that the pump purge sidearm could leak purge fluid and the system could stop pumping.
