The US subsidiary of Johnson & Johnson is recalling 90,000 heart pumps worldwide

Caused 49 deaths and 129 serious injuries, the United States Johnson & Johnson subsidiary recalled 90,000 heart pumps worldwide, the Chinese mainland is not affected

On March 30, local time, according to media reports, due to safety risks, the US Food and Drug Administration (FDA) issued a Class I recall for a heart pump, that is, the highest level of alert. More than 66,000 devices have been recalled in the United States.

The heart pump is capable of providing short-term support for pumping blood in the ventricles during medical procedures or after a serious heart attack. The FDA says the pump's catheter can puncture the heart's left ventricular wall during surgery and cause serious adverse outcomes, including left ventricular perforation, rupture of the free wall, high blood pressure, inadequate blood supply, and death. So far, 49 people have been killed and 129 seriously injured.

The Impella heart pump is manufactured by Abiomed in the United States and will be in service from October 10, 2021 to October 10, 2023.

       90,000 units of six models are recalled worldwide，China is unaffected

Red Star News reporters consulted the database entry information and found that the global recall of Impella heart pumps involved a total of six models, They include Impella 2.5, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist, Impella CP, and Impella CP with SmartAssist.

Impella 5.5 rendering with SmartAssist functionality

The Impella ECP, dubbed the "world's smallest artificial heart" (with a diameter of just 3mm), is not part of the recall.

The recall covers a wide range of products, including the United States, Japan, Australia, Canada, Germany, France, India, Mexico and many other countries, as well as Taiwan. A total of 66,390 products have been recalled within the United States, while more than 26,000 products have been recalled outside the United States. 

         There were three Class I recalls last year, and this year's is the largest

The Impella heart pump was originally designed to provide temporary support to a patient's heart during high-risk surgery or after a serious heart attack. However, the FDA notes that if used improperly, the device's catheters can puncture the heart, leading to a range of serious health problems, including high blood pressure, inadequate blood flow and even death.

In the past year, the Impella heart pump has undergone four Class I recalls, which is considered the highest warning in the U.S. medical device industry and means that the use of the device may pose serious risks, even life-threatening.

In April 2023, the company issued a partial recall of Impella 5.5 heart pumps with SmartAssist functionality due to leaking cleaning fluid.

In June 2023, Abiomed also issued a recall of the Impella RP Flex heart pump after clotting was higher than expected. That same month, Abiomed warned of a possible interaction problem between the Impella heart pump and a transcatheter aortic valve replacement (TAVR) stent, and the FDA received four reports of deaths related to this.

In a subsequent inspection, the FDA found that Abiomed delayed issuing a recall notice even after receiving an "unacceptably high" complaint rate about the Impella 5.5 heart pump, issuing a warning letter. The letter also said the company used software that was not authorized by the FDA.

In July 2023, Abiomed issued a Class I recall for the Impella heart pump due to possible interference between the devices and the stent of the TAVR valve, resulting in injury to the device. Despite the severity of the recall, Abiomed does not actually recall the product, but instead alerts medical personnel to potential risks through its "issue a recall" initiative and emphasizes that the product does not need to be recalled or replaced.

In 2024, Abiomed recently launched the largest recall in its history, recalling six models of Impella heart pumps worldwide. The main measure is to change the instructions for use and add five new warnings about the risk of ventricular perforation.

$16.6 billion acquisition of "artificial Heart", Johnson & Johnson response: has updated the instructions

Johnson & Johnson issued a statement in response to the recent high-profile recall of its Impella heart pump, clarifying that the recall does not mean the product is being removed from store shelves. A Johnson & Johnson spokesperson said the Impella artificial heart is still on the market for patients to use, according to China Business News. The company also said it has updated the instructions for use of the Impella system to further address the potential risk of left ventricular perforation, a rare complication.

Impella is currently the only commercially available product approved by the US FDA and the earliest commercially available interventional artificial heart. As of November 2023, more than 300,000 patients worldwide have been treated with Impella products.

Abiomed, maker of the Impella, has seen its share price soar on the back of its flagship product. According to the National Business Daily, from March 2009 to June 2018, Abiomed's share price rose more than 79 times in less than 10 years, surpassing streaming giant Netflix to become the "strongest stock" in the S&P 500 index. In fiscal 2022, Abiomed had revenue of more than $1 billion, with Impella contributing more than 95 percent of the revenue to $985 million.

In November 2022, Johnson & Johnson acquired Abiomed for $16.6 billion in a bid to boost growth in its medical device division. The acquisition is not only J&J's first major deal since it announced the spin-off of its consumer health business, but also the largest acquisition in its history. After being acquired by Johnson & Johnson, Abiomed was delisted with a pre-delisting market value of $17.181 billion. However, shortly after the acquisition was completed, Abiomed was caught in a storm over the recall of its Impella heart pump.

Tim Kaufmann, co-founder and chairman of artificial heart developer Life Shield Medical, said, "The Impella recall is not the first case in the industry, and it further demonstrates that we as medical device developers have to be extremely meticulous." But he doesn't think the recall will stop innovation in artificial hearts. "It is precisely in this area that we need more competition, and all of us must always remember to work with the utmost care to address any problems that may arise."

Another senior person in the medical device field said that the US FDA has been in the forefront of approving innovative medical devices, encouraging the listing of innovative devices, but the product will be very strict after the market monitoring of adverse events, once found errors will be recalled in time to correct errors