FDA Initiates Class I Recall of Medtronic HeartWare HVAD System

A HeartWare HVAD System recall has been classified as a Class I recall by the U.S. Food and Drug Administration (FDA) due to potential damage as a result of loose connections. Class I recalls are the most serious type of recall, which indicates that there is a reasonable risk of serious adverse health consequences or death. Affected patients and their families may be eligible to pursue compensation with the help of a defective medical device lawyer.

For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated HeartWare HVAD System recall attorney who can assist you throughout the legal process.

Important: The time you have to pursue a claim is limited. Contact us for more information.

Damaged Devices Could Lead to Serious Injury or Death

Medtronic PLC has announced that a previous voluntary recall associated with the HeartWare HVAD System has been classified as Class I by the FDA. According to a press release issued by Medtronic, physicians and health care providers have been notified of the potential damage to controllers from exposure to moisture through loose power and data connectors. The HVAD System includes a ventricular assist device (VAD), a mechanical pump that pumps blood to the body when one of the heart’s natural pumps does not properly operate, and a controller that monitors the pump’s activities.

Recalled controllers include:

  • Model No. 1400
  • Model No. 1401

Approximately 8,799 potentially affected HVAD HeartWare Controllers were distributed, and as of September 2016, 308 controllers have been replaced worldwide. Hospital clinicians have been advised to inspect patients’ HVAD HeartWare Controllers for loose connectors and replace affected controllers if needed. Damage to the controllers could potentially lead to a lose of communication between the controller and monitor, possibly reducing the device’s ability to detect alarms or interruption, which could lead to serious injury or death. Adverse reactions or quality problems with the use of the HVAD System can be reported to the FDA’s MedWatch Adverse Event Reporting program.

How a HeartWare HVAD System Recall Attorney Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by a defective HVAD System may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group. You can fill out the form on this page or contact us by phone or email.

After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.