Impella left-sided heart pumps are used to support the blood-pumping ventricles of the heart during surgery for opening a blocked artery or clearing blockages after a heart attack. They may also be used during open heart surgery, post-heart attack, when an individual’s heart has been damaged to the extent that it can no longer supply sufficient blood or oxygen to the body (cardiogenic shock), or for those who suffer from diseases of the heart muscle (Cardiomyopathy). Use of the pump is aimed to allow the heart to recover while maintaining the circulatory system.
On December 27, 2023, the FDA issued a class I recall for the left sided pumps manufactured by Abiomed. The devices have been found to result in serious injuries and even death. The left sided Impella pumps may cut the wall of the left chamber of the heart or cut through it during operations. The product has been linked to 49 deaths and dozens of injuries worldwide, with older adults, women, and people with heart disease being particularly at risk. In the U.S., 66,390 devices have been recalled.
Although the recall is the most serious level available to the FDA, it falls short of requiring the manufacturer to remove the devices from the market entirely. Abiomed has advised doctors and medical facilities to proceed with more caution, issuing a list of additional warnings, adding to an already lengthy instruction manual. The company has known about the risks for several years but failed to appropriately notice the FDA. Doctors raise concerns that there is limited research available showing that the benefits of the devices outweigh the risks.
Contact a Locks Law Firm Personal Injury Lawyer
If you or you or a loved one had one of the following Abiomed Impella Heart Pump devices implanted between October 10, 2021, and October 10, 2023:
Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist, or Impella LD,
Contact the Pennsylvania, New Jersey or New York Offices of the Locks Law Firm today to schedule a free, confidential consultation and case evaluation.
Sources:
https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks
https://medlineplus.gov/cardiomyopathy.html
https://medlineplus.gov/ency/article/000185.htm
https://www.nytimes.com/2024/03/29/health/fda-heart-pump-fatalities.html
