FDA: Recall Issued for HeartMate II LVAS Pocket System Controllers

Abbott-Thoratec is recalling the HeartMate II LVAS Pocket System Controller due to the risk of patient injury and/or death while exchanging backup controllers during the course of ventricular assist therapy. Affected patients and their families may be eligible to seek 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 pocket system controller recall lawyer who can assist you throughout the legal process.

The time you have to pursue a claim is limited. Contact us for more information.Get Help Now.

26 Deaths Linked to Controller Exchange Away From Hospital

The Pocket System Controller is a power supply used to connect implanted HeartMate II Left Ventricular Assist (LVAS) heart pumps through a lead under the skin. The devices may be used inside or outside of the hospital; however, it is suggested that patients exchange the controllers in the hospital because untrained patients may have difficulty properly changing the devices. According to the U.S. Food and Drug Administration (FDA), Abbott-Thoratec has received a total of 70 reports of incidents, including 19 injuries and 26 deaths, which occurred when patients attempted to exchange controllers while away from the hospital.

Over 28,000 devices are being recalled in the United States. Recalled devices were manufactured between July 2012 and December 2016, and distributed between July 2012 and March 2017. The following model/item numbers are being recalled:

  • 105109
  • 106015
  • 106762
  • 107801

On March 29, 2017, Abbott-Thoratec sent an “Urgent Medical Device Correction” letter to affected patients outlining the company’s intentions to provide users with new software and hardware updates to assist them in changing their pocket controller systems in emergency situations.

How a Pocket System Controller Recall Lawyer 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 Pocket System Controller 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.