HeartWare HVAD Subject of Recall and Safety Warnings
The HeartWare HVAD is a ventricular assist system manufactured by HeartWare Inc.
Medscape reports the HeartWare HVAD was FDA approved in November 2012 as a bridging treatment for people with heart failure awaiting a heart transplant. CardioVascular Business reports that over 4,000 HeartWare HVADs have been implanted worldwide.
According to the National Institutes of Health, a ventricular assist device is a mechanical pump used to support the heart and ensure blood flow in patients with failing hearts.
FDA Class 1 Recall for HeartWare HVAD Driveline Connector
The FDA reports that devices with the following criteria fall under the recall:
- Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205
- Serial Numbers: HW001 to HW11270 and HW20001 to HW20296
- Manufactured from March 6, 2006 to October 17, 2013
- Distributed from March 17,2006 through November 29, 2013
HeartWare originally warned doctors and patients in December 2013 about the driveline connector becoming disengaged and leading to the HeartWare HVAD’s pump stopping, according to FierceMedicalDevices.
HeartWare Warns of Premature Battery Depletion
On May1, 2014, HeartWare issued a voluntary correction notice about battery depletion occurring earlier than expected, according to MedicalDevice Network.
FierceMedicalDevices reports the voluntary correction notice for the HeartWare HVAD batteries came in response to a large increase in patient complaints. The correction notice applies to batteries with the product codes 1650 and 1650-DE, according to Cardiovascular Business.
Medical Devices Business Review reports that between January 1, 2011 and March 31, 2014, HeartWare received reports of 3 deaths related to power source management.
While the Framingham Patch reports the FDA has received 238 complaints about premature battery depletion and has 119 MDR events listed.
HeartWare HVAD Failure and FDA Warning Letter
Medscape reports HeartWare received 27 complaints of controller failure, most likely due to electrostatic discharge, which resulted in the deaths of 2 people and serious injuries in 4 others.
The Worcester Business Journal reports that the FDA sent a warning letter to HeartWare alleging design and software malfunctions might have lead to deaths and serious injuries. The letter from the FDA, dated June 2, 2014, reports:
- HeartWare was not in conformity with current good manufacturing practice
- HeartWare failed to appropriately handle complaints and implement corrective and preventive action
- HeartWare failed to validate device design and validate computer software