According to the United States Food and Drug Administration (FDA), Abiomed’s Impella Left Sided Blood Pump can perforate the wall of the heart’s left ventricle. This may lead to several health problems, including free wall rupture, hypertension, no blood flow, or death.
The FDA has termed this a Class I recall. This product recall designation is given to a product that “may cause serious injuries or death.”
This is the most severe type of medical device recall. The New York Times has linked the Abiomed pumps to at least 49 deaths and over 120 serious injuries.
Abiomed Impella Blood Pump Recall List
The recalled Abiomed Impella devices include:
- Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD
- Distribution Dates: October 10, 2021 to October 10, 2023 (More than 66,000 devices in the US)
Abiomed Impella Blood Pump Complications
Potential complications of the Abiomed Impella devices include:
- Heart ventricle perforation
- Free wall rupture,
- Hypertension,
- No blood flow, or
- Death
It should be noted that this device is still on the market and available for patients. Instead of pulling the product, Abiomed updated the instructions for use with additional warnings.
Abiomed is a cardiovascular medical technology company owned by Johnson & Johnson. In 2023, Johnson & Johnson had $85 billion in revenue.
Questions About a Abiomed Impella Blood Pump Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review
If a recalled Abiomed Impella Blood Pump injured you or a loved one, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new cases for recalled medical devices nationwide, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please use the form below to contact us or call (800) 279-6386. We would be honored to speak with you and respond promptly to every inquiry.
Free Case Evaluation
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (800) 279-6386.