HeartWare Ventricular Assist Devices have been recalled. The manufacturer, HeartWare, 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.
The HeartWare Ventricular Assist System is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure. The System includes various internal and external components including but not limited to the internal pump, external controller, power sources, and the driveline connecting the pump to the controller. The HeartWare Ventricular Assist System, also known as HeartWare Ventricular Assist Device (HVAD), is designed for in-hospital and out-of-hospital settings, including transportation by fix-wing aircraft or helicopter.
The recall applies to products with Serial Numbers: HW001 to HW 11270 and HW20001 to HW 20296. Affected products were manufactured from March 6, 2006 through October 17, 2013 and distributed from March 17, 2006 through November 29, 2013.
Physicians were asked to promptly arrange a follow up visit with patients having the affected HVAD to inspect the driveline connector. At implant and at each routine clinic visit, physicians should inspect the patient’s driveline connector for proper locking and to ensure that the connector assembly remains secure.
During the inspection, physicians should pull back the protective boot and slide the locking mechanism back and forth to verify free movement of the mechanism. If the locking mechanism of the driveline connector does not move freely or fails to engage, the physician should push the connector back into the controller and immediately contact a HeartWare Clinical Engineer to perform a permanent field repair.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues