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HeartWare HVAD Lawsuit

HeartWare HVAD Lawsuit

The HeartWare Ventricular Assist System (HVAD), a heart pump used in patients with heart failure, has been recalled. HeartWare has received 8 reports of a defect that could cause the pump to stop working, which may cause patient injury or death.

What You Can Do & How a HeartWare HVAD Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting HeartWare HVAD induced injury cases in all 50 states. If you or somebody you know was 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 us toll-free 24 hours a day at (866) 920-0753.

UPDATE: HeartWare HVAD Recalled for Faulty Battery Issue

August 5, 2014 — HeartWare Inc. has announced a voluntary recall of their HVAD to address safety problems with batteries that can deplete earlier than expected. Click here to read more.

June 4, 2014 — Six months after recalling a device for manufacturing problems, HeartWare says it has received a warning letter from the FDA after inspectors found problems at manufacturing facilities in Florida. Click here to read more.

What is the HeartWare HVAD?

HeartWare International Inc. manufactures the HeartWare Ventricular Assist System (HVAD), an implanted left-sided heart pump that provides continuous flow through the heart of patients with end-stage heart failure.

The HeartWare LVAD is also called a “bridge to transplant” because it is used in patients who are awaiting a heart transplant. It can be used in a hospital or when patients are being transported to a transplant center on an aircraft or helicopter.

Recall Information

April 29, 2014 — The U.S. Food and Drug Administration (FDA) has published a Safety Alert to announce the Class I recall — the most serious type of recall. The recall was initiated in December 2013 with an Urgent Medical Device Correction Notification to customers.

Reason for the Recall

“The company received reports where the driveline connector locking mechanism has failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death.”

Products Included in Recall

Products with catalog numbers: 1100, 1101, 1102, 1103, 1104, and 1205 with serial numbers ranging from: HW001 to HW11270 and HW20001 to HW20296. Sold from March 17, 2006 through November 29, 2013. Devices manufactured since November 2013 do not have the same problem.

Recommendation

Patients: Discuss the recall with your doctor or your VAD coordinator. Do NOT attempt to disconnect or inspect the driveline yourself. If the driveline becomes disconnected from the patient controller, a “VAD Stopped” alarm will alert you. Immediately reconnect the driveline to the controller and contact your doctor or VAD coordinator.

Doctors: Inspect your patient’s driveline connector for proper locking with each routine clinical visit to ensure the connector assembly remains secure. If the locking mechanism fails to engage or the driveline disconnects from the controller, the driveline connector should be pushed back into the controller immediately. Contact a HeartWare representative to arrange for a permanent repair.

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 was 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 us toll-free 24 hours a day at (866) 920-0753.

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