The Heartware Ventricular Assist System has recently been found to have a manufacturing defect that may increase the risk of serious injury and even death to patients. As a result of these problems, the Food & Drug Administration is advising healthcare professionals to schedule follow-up appointments with patients implanted with the affected devices to inspect them. Our lawyers are now investigating potential lawsuits for patients who have been injured by the Heartware Ventricular Assist System.
FDA: Locking Mechanism of HVAD Pump Driveline Connector May Fail to Engage
On April 29, 2014, the FDA issued a Class I Recall Announcement which stated that HeartWare Inc. had received multiple reports of its Ventricular Assist System driveline connector locking mechanism failing to engage. When this occurs, it may result in the pump stopping and causing severe health outcomes, including death.
Also known as the HeartWare Ventricular Assist Device (HVAD), this product is used as a bridge to cardiac transplantation in patients at risk for developing heart failure. HVAD is designed for in-hospital and out-of-hospital use, including transportation by plane or helicopter.
Which HVAD Devices are Being Recalled?
According to the FDA, this Class I Heartware Ventricular Assist System Recall affects devices with the following:
- Catalog numbers – 1100, 1101, 1102, 1103, 1104, and 1205
- Serial Numbers – HW001 to HW 11270 and HW20001 to HW 20296
HVAD devices included in this recall were made between March 6, 2006 and October 17, 2013, and distributed from March 17, 2006 through November 29, 2013.
FDA is advising healthcare professionals to schedule a followup appointment with patients having the affected Heartware Ventricular Assist System to look at the driveline connector. During the initial surgery and at each subsequent visit, the doctor should inspect the patient’s driveline connector for proper locking, and to ensure that the connector assembly remains in place. During the inspection, the doctor should pull back the protective boot and slide the locking mechanism back and forth to verify movement of the component. If the locking mechanism fails to move freely or engage, the doctor should push the connector back into the controller and contact HeartWare Inc. immediately to have a company engineer perform a permanent field repair.
Do I Have a Heartware Ventricular Assist System Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Heartware Ventricular Assist System Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one has been injured after receiving a Heartware Ventricular Assist System, you should contact our law firm immediately. You may be entitled to compensation by filing a Heartware Ventricular Assist System Suit and we can help.