Abiomed Issues Recall For Impella Left Sided Blood Pumps

Johnson & Johnson Subsidiary Abiomed Issues Recall For Left Sided Blood Pumps Due To Risk They Can Perforate Hearts During Procedure

Abiomed Issues Recall For Impella Left Sided Blood Pumps

CHICAGO, ILLINOIS (June 28, 2024) – Johnson & Johnson subsidiary Abiomed has issued a recall for its Impella left-sided blood pumps because they can puncture hearts during procedures.

The Food and Drug Administration (FDA) has received 129 reports of serious injuries, including 49 deaths related to the blood pumps.

The Impella left-sided blood pumps were used in order to support a patient’s heart during various procedures, including cariogenic shock.

Abiomed has also received a warning letter from the FDA for quality problems with Impella and the software used in the device. It turns out that they were not authorized by the agency.

The major problem with the device is that the catheter can cut through the wall of the left ventricle. An estimated 66,000 devices were part of the recall.

The affected devices were sold between October 2021 and October 2023.

Liability For Injuries Involving Faulty Medical Devices

Deaths and serious injuries involving medical devices are extremely common. According to data from the Food and Drug Administration, an estimated 80,000 deaths and 1.7 million injuries have been linked to medical devices over the past 10 years. There are a number of factors that could contribute to deaths involving medical devices.

  • Design Flaws: Poorly designed devices can malfunction or even fail. Design flaws could include inadequate safety features as well as substandard materials.
  • Manufacturing Defects: Many medical devices can develop defects during the creation of the device. For example, a device may inadvertently develop sharp edges that can result in cuts.
  • Software Errors: Many medical devices rely on software, especially for devices used in surgery. If this software glitches, patients can be seriously injured or killed.
  • Unclear Instructions: Medical devices can be extremely difficult to operate. If the instructions for the device are not clear, this will increase the odds that the device will be misused.

Companies that manufacture medical devices have a legal obligation to ensure that they are reasonably safe. These companies must ensure that their devices are compliant with all safety standards set by the Food and Drug Administration. In general, companies can be strictly liable for the design defects associated with their products.

It is also possible for a doctor or hospital to be liable if a patient is injured in their care. Medical providers have a legal obligation to protect their patients from reasonably foreseeable sources of harm. If a doctor’s standard of care deviates substantially from what other doctors would have done in a similar situation, this could be construed as medical malpractice. It is important that certain steps are taken after any injury or death involving a medical device.

  • Eyewitnesses should be interviewed.
  • Medical records related to the incident should be preserved.
  • A thorough investigation should be conducted.
  • An experienced product liability attorney should be contacted.

Injuries and deaths involving medical devices can be very complex events. It is important for victims to seek legal advice as early as possible. Any person injured by a medical device may be able to seek compensation through a civil claim. A product liability attorney can examine all of the unique facts of your case and let you know what your legal options are.

Getting Legal Help After Injuries Involving Medical Devices

We at Horwitz Horwitz & Associates were deeply concerned to hear about all of the injuries and deaths involving the Impella left-sided blood pumps. There needs to be a thorough investigation into what went wrong. It is our sincere hope that measures are taken to prevent other unsafe devices from reaching hospitals.

Have you or someone that you care about been injured by an Impella left-sided blood pump? You may have legal recourse. Our team of product liability attorneys is here to answer any questions that you may have. We care deeply that victims of unsafe medical devices get the support and justice that they are entitled to. Whether you just have legal questions or are thinking about hiring an attorney, we are here to serve your needs. You can reach out to us anytime at (312) 564-4256.