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FDA Issues Alert Over Heart Pump Deaths

A device meant to improve the outcomes of heart patients in life-threatening conditions is under fire from the FDA for its risk of puncturing the heart.

Abiomed, a medical device manufacturer owned by Johnson & Johnson MedTech since 2022, is recalling instructions for using its Impella left-sided blood pumps. Forty-nine deaths and 129 injuries nationwide have been linked to the pumps’ catheters, which may puncture the heart’s left ventricle.

Exterior view of the sign at the headquarters of the US Food and Drug Administration

Unlike most FDA recalls that require users to return or discontinue the device in question, this alert allows continued use of the heart pump. The agency instructed Abiomed to update the risks in its 243-page Impella instruction manual to include perforation. The recall is considered Class 1, the most serious action besides removing the device from the market. Class 1 recalls are reserved for devices with a high risk of severe injury or death.

The Impella pumps are about the size of a candy cane and threaded through blood vessels during surgery. They’re temporary implants that take over the heart’s basic function of moving blood through the body while severely ill patients – often with a mortality risk of 40 to 50 percent – undergo complicated procedures. 

The pumps could also cause left ventricle free wall rupture, hypertension, and lack of blood flow, which all significantly increase the chance of death in patients whose hearts are already extremely weak. 

UCLA cardiologist and Assistant Professor of Medicine Dr. Boback Ziaeian told The New York Times that heart wall rupture caused by a device is “a surgical emergency that very rarely people survive from.” 

There are currently 66,000 Impella pumps being used in the U.S. and 26,000 others internationally. 

The specific devices in the recall include the following models distributed between October 10, 2021-2023: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella LD, Impella 5.0 and Impella 5.5 with SmartAssist. 

SmartAssist technology, according to Abiomed, uses optical sensors and advanced metrics to improve cardiologists’ ability to position the pump, identify right heart failure, and assess blood flow.

FDA records showed that Abiomed attributes the heart-wall tears to cardiologists’ handling of the pumps, urging them in the recall notice to use imaging tools in tandem with the devices to avoid perforation. J&J also said that heart-wall tears are a rare but “known complication during invasive cardiology procedures.”

Some doctors told the Times that they’re concerned about the lack of high-quality studies proving the pumps are more helpful than harmful, and believe simply adding instructions in the manual won’t decrease the risks.

“I think cardiologists are already extremely careful,” said Dr. Rita Redberg, cardiologist and professor at UC San Francisco. “To say that you’re addressing 49 deaths by saying ‘be careful’ is not addressing the problem at all.”

Multiple studies over the last decade have indicated that using the Impella pumps heightens the risk of serious bleeding and death.

In a 2019 study comparing the Impella pump to a standard intra-aortic balloon pump in patients with cardiogenic shock, researchers found a difference of just 2.1 percent in the 30-day mortality rate, or patients who were alive one month post-surgery.

The new recall, which was issued in December 2023, is the third major action the FDA has taken on an Impella device in one year.

In April 2023, Abiomed recalled certain sets of the Impella 5.5 with SmartAssist after reports that the pump was leaking purge fluid, which prompts an alarm and requires immediate evaluation to avoid device failure. The most critical patients will rapidly deteriorate if their pumps are leaking fluid, said the FDA.

The FDA also found that Abiomed posted an update on its website about the Impella pumps’ risk of perforation in October 2021, but did not notify the agency, which requires companies to file a report on any discovered risks within 10 days.

Had they done so, said FDA spokeswoman Audra Harrison, the agency could have issued a large-scale warning to doctors and hospitals.

Patients with questions about the newest recall should consult their cardiologists or contact Abiomed at 978-646-1400.