FDA Warns About Impella Left-Sided Blood Pumps, Linked to 49 Deaths

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) issued an alert about the Impella left-sided blood pumps, now linked to 49 deaths and 129 reported serious injuries worldwide.¹ According to the FDA, the heart pump could puncture a wall in the left ventricle of the heart, and during surgery, the device could cut through the wall.

The FDA identified this as a Class I recall, following the Class 1 recall of all Impella left-sided blood pumps for risk of motor damage after contact transcatheter aortic valve replacement (TAVR) which resulted in 30 complaints and 4 deaths.²

Other than death, the recalled Impella heart pump could lead to serious adverse health outcomes, such as left ventricle perforation or free wall rupture, hypertension, and lack of blood flow. Older adults, women, and people with heart disease are the ones most at risk for heart-wall tears from the Impella heart pumps.

Abiomed sent all affected customers an Urgent Medical Device Correction letter with updated instructions and new warnings.

Abiomed, the manufacturer of the device, posted about the pump’s perforation risk on their website over 2 years ago in October 2021 but did not notify the FDA. FDA said if they had known, there would have been greater warning to hospitals and doctors about the risk.³ Since the published notice, the FDA received 21 reports of heart-wall tears leading to patients’ deaths.

Later, Abiomed acted like the Impella devices did not have complications. When Johnson & Johnson MedTech bought Abiomed in 2022, Seth D. Bilazarian, a senior vice president of Abiomed, put out a statement saying 300,000 Impella devices had been used in patients worldwide for more than a decade, and there were no reports of heart-wall perforations due to manufacturing errors. When asked why Abiomed did not report the deadly risk, they said it was because they were working on broad improvements, and the heart-wall tears were “rare” and a “known complication.”

The FDA did not learn about the Impella heart pump’s malfunctions until an inspection last year at Abiomed’s Massachusetts headquarters where inspectors found several non-reported complaints about the devices and a bulletin dated October 2021—the same one posted on Abiomed’s website—describing the tearing risk.⁴ The bulletin said the heart pump’s “rare complication” was first noted in January 2018.

Copious research hinted at the potential danger of the device. A study back in 2013 saw the potential for the heart pump to sever vessels and lead to serious bleeding.^5,6 Several studies found Impella heart devices increased the risk of death in patients with unstable medical conditions.

Some cardiologists have already questioned the role of the pumps due to the lack of high-quality data and wondered if an update on the risks in the dense instruction booklet would even avert deaths.

“I think cardiologists are already extremely careful,” Rita F. Redberg, a cardiologist and a professor at the University of California, told The New York Times.³ “To say that you’re addressing 49 deaths by saying ‘be careful’ is not addressing the problem at all.”

^References

1. ^{Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks. US Food and Drug Administration. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks?utm_medium=email&utm_source=govdelivery. Accessed March 29, 2024.}
2. ^{Campbell, P. FDA Announces Class I Recall of All Left-Sided Impella Pumps. HCPLive. July 27, 2023. https://www.hcplive.com/view/fda-announces-class-i-recall-of-all-left-sided-impella-pumps. Accessed March 29, 2024.}
3. ^{Jewett, C. Heart Pump Is Linked to 49 Deaths, the F.D.A. Warns. The New York Times. March 29, 2024. https://www.nytimes.com/2024/03/29/health/fda-heart-pump-fatalities.html?ugrp=u&unlocked_article_code=1.gU0.upLt.09R1gaQU6YaL&smid=url-share. Accessed March 29, 2024.}
4. ^{Abiomed, Inc. US Food and Drug Administration. September 19, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abiomed-inc-663150-09192023. Accessed March 29, 2024.}
5. ^{Manzo-Silberman S, Fichet J, Mathonnet A, et al. Percutaneous left ventricular assistance in post cardiac arrest shock: comparison of intra aortic blood pump and IMPELLA Recover LP2.5. Resuscitation. 2013;84(5):609-615. doi:10.1016/j.resuscitation.2012.10.001}
6. ^{Schrage B, Ibrahim K, Loehn T, et al. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019;139(10):1249-1258. doi:10.1161/CIRCULATIONAHA.118.036614}