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HeartWare Gets FDA Warning Letter

HeartWare Gets FDA Warning Letter

June 4, 2014 — HeartWare International Inc. has received a warning letter after inspectors from the U.S. Food and Drug Administration (FDA) found problems at a manufacturing facility in Miami Lakes, Florida.

HeartWare said the FDA asked them to address problems in four areas:

  • Procedures for validating device design and labeling
  • Procedures for implementing corrective and preventative action
  • Maintaining records related to investigations
  • Validation of computer software used as part of production or quality systems

The FDA did not place restrictions on any HeartWare devices. The company “expects to implement new and enhanced systems and procedures” and to “perform additional actions as may be required to resolve the issues raised in the FDA communication.”

In December 2013, HeartWare issued a Class I recall of the Ventricular Assist Device (HVAD). Manufacturing problems caused the driveline connector locking mechanism to fail to engage, which could cause the pump to stop working unexpectedly.

On May 1, HeartWare issued another warning after finding that some batteries could deplete earlier than expected. The company offered to replace fully-charged batteries that ran out within two hours. No deaths were directly linked to the problem, but HeartWare said that power source problems were possible responsible for three deaths.

The HeartWare HVAD is an implantable heart pump that is used to continuously push blood through the heart of patients with end-stage heart failure. It is also known as a “bridge to transplant” because it is used in people who are awaiting a heart transplant, in transit, or are too sick to have surgery.

Do I have a HeartWare HVAD Lawsuit?

The Schmidt Firm, PLLC is currently accepting HeartWare HVAD induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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