Impella Heart Pump Linked to 49 Deaths and 129 Severe Injuries Triggers Largest-Ever Class I Recall

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According to CCTV News: Due to safety risks,A heart pump product from Johnson & Johnson has caused 49 deaths and 129 serious injuries. The U.S. Food and Drug Administration has issued a Class I recall for the product.

The heart pump subject to this recall is named Impella, an implantable left ventricular assist system that provides short-term support for blood pumping in the ventricle during doctor surgeries or after severe heart attacks. However, the FDA found,This heart pump may pierce the left ventricular wall, causing left ventricular perforation, free wall rupture, hypertension, insufficient blood supply, and death.And many other adverse consequences.

Currently, the United States has recalled more than 66,000 of these heart pumps. However, this product has been exported to multiple countries including the United States, Japan, Australia, Canada, and Germany, with over 26,000 units being recalled outside the United States.Jianshi Bureau learned that the relevant products have not been issued in mainland China.

Johnson & Johnson spokesperson stated that the Impella heart pump remains on the market for patient use. The product’s instructions for use have been updated to further address the potential risk of complications such as left ventricular perforation.

Recalled multiple times last year

A heart pump is a type of artificial heart product. The Impella heart pump, developed and manufactured by Abiomed, is the world's first commercially available artificial heart. It was successively launched in Europe and the United States in 2005 and 2008. Over the following decade, the product underwent upgrades and new models were continuously introduced to the market. In 2022, Abiomed achieved revenue exceeding 1 billion US dollars due to the outstanding performance of the Impella heart pump. As of November 2023,More than 300,000 patients worldwide have used this artificial heart.

November 2022,Johnson & Johnson Spends $16.6 Billion to Acquire AbiomedThis is one of the largest acquisitions in Johnson & Johnson's history, with the hope of surpassing Medtronic in the field of cardiac intervention.

Unexpectedly, less than two years after the acquisition, the Impella heart pump triggered the largest recall in the history of artificial heart products.

Jian Shi Ju learned that Johnson & Johnson is recalling six models of Impella heart pumps globally. At the same time, the instructions for use are being updated with five new warnings about the risk of ventricular perforation.Johnson & Johnson responded by stating that the recall clarification does not mean the product is being taken off the shelves.

In fact, this is not the first recall of the Impella heart pump.

Before being acquired by Johnson & Johnson,In April 2023, Abiomed partially recalled the Impella 5.5 heart pump due to leaking cleaning fluid.In June 2023, Abiomed initiated another recall of the Impella RP Flex heart pump.FDA Receives 4 Death Reports, Related to potential interaction issues between the Impella heart pump and transcatheter aortic valve replacement stents. Abiomed has initiated a Class I recall of the affected heart pumps, involving 7,900 problematic units.

However, these related devices remain in medical institutions, and Abiomed has issued usage warning information to medical staff.

This time, Johnson & Johnson must initiate a global recall of the Impella heart pump. However, it is widely believed in the industry that this will not hinder the research and development of products in the artificial heart field. On the contrary, the entry of more enterprises will accelerate market competition, forming an elimination mechanism that will lead to more perfected and safer artificial heart products.

Medtronic has withdrawn from the competition

According to authoritative statistics, the number of heart failure patients worldwide exceeds 22.5 million people, increasing at a rate of 2 million people per year, with a market capacity behind it exceeding$25 billion. Medtronic, Abbott, and Johnson & Johnson have all planned to enter this market.However, artificial heart products seem to be not safe.

In August 2021, the FDA announced on its official website: Due to the risk of neurological adverse events, death, and possible failure to restart,Medtronic Recalls HeartWare HVAD Implantable Left Ventricular Assist System. This incident involves 14 deaths.FDA Designates Class I Recall, Affecting 4,620 Devices.

Medtronic has since fallen into a decline, announcing the cessation of sales and the discontinuation of providing related products to hospitals, thereby exiting the competition in the left ventricular assistive therapy field.

Abbott is also having a tough time. In March this year, Abbott's HeartMate Touch communication system for left ventricular assist devices injured eight people, prompting the FDA to issue a Class I recall. This recall involves 1,560 devices sold in the U.S. Abbott’s products have gone through three rounds of iterations.HeartMate Touch is already the third generation of centrifugal pump technology (magnetic levitation), which should be said to be safer in performance, but serious risks have also emerged.

Since 2019, in China,CH Biomedical, EVAHEART Medical, Core Medical, and Space TH HeartLeft Ventricular Assist Devices Developed by Four Companies Have Been Successively Approved for Marketing. In Addition, Multiple Companies Are Actively Developing Implantable Artificial Heart Products.

Chinese companies developing artificial hearts have not mentioned any safety-related risks associated with their products. They only indicated that, at the application level, long-term clinical use may lead to side effects such as thrombosis and bleeding.

Current treatment options for patients with advanced heart failure are very limited, and artificial hearts may be considered the only product capable of extending patient survival. However, several experts have pointed out that even patients with successful surgeries still require long-term observation post-operation.