HeartWare has issued a Class I recall of the HeartWare Ventricular Assist System (HVAD), a heart pump, after receiving eight reports that a defective locking mechanism on the driveline connector could cause the pump to stop working. This could result in serious complications, including death.
Need a Texas HeartWare HVAD Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
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 Ventricular Assist System?
HeartWare Inc. manufactures the HeartWare Ventricular Assist System (HVAD). The system consists of internal and external components, including a heart pump, external controller, power sources, and the driveline connecting the pump to the controller.
When is the HeartWare HVAD Used?
The HeartWare HVAD is used in patients with severe heart failure who are at risk of death. It is a so-called “bridge to transplant” for patients who are too weak to have a heart transplant or are awaiting an available organ. The HeartWare HVAD is used in the hospital and also out-of-hospital settings, including transportation by aircraft or helicopter.
HeartWare HVAD Recall Information
HeartWare initiated the recall in December 2013, by sending an Urgent Medical Device Correction Notification to customers. The affected products were sold from March 17, 2006 through November 29, 2013.
Recalled HeartWare Systems carry catalog numbers: 1100, 1101, 1102, 1103, 1104, and 1205 with serial numbers ranging from: HW001 to HW11270 and HW20001 to HW20296. All devices manufactured since November 2013 incorporate changes in manufacturing procedures which address this issue.
Reason for 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.”
On April 29, 2014, the U.S. Food and Drug Administration (FDA) classified the action as a Class I recall — the most serious type — and published a Safety Alert.
What Should I Do?
Patients should discuss the recall with their physician or VAD coordinator. Clinicians should inspect the patient’s driveline connector for proper locking at each routine clinic visit to ensure that 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. Clinicians should promptly call their HeartWare representative to arrange a permanent repair.
Need a HeartWare HVAD Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas HeartWare HVAD lawyers for a free lawsuit review.