HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc. : Class I Recall – Contamination Causing Electrical Issues
HeartWare Inc. is recalling its HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump. The HVAD is designed for use both in and out of hospital settings, including during patient transport. This recall affects all HVADs with serial numbers lower than HW25838, Product Codes 1103 and 1104, manufacturing dates: March 17, 2006 to June 27, 2016. 105 units have been recalled in the U.S.
Read the MedWatch safety alert, including links to the Recall Notice, at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526416.htm
HeartWare Inc. is also recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death.
This recall relates to the following HVAD controllers:
- Serial Numbers: HW001 to HW11270, and HW20001 to HW 20296
- Product Codes: 1100, 1101, 1102, 1103, 1104, 1205
- Manufacturing Dates: March 6, 2006 to October 17, 2016
Read the MedWatch safety alert, including a link to the Recall notice, at:
If you or a loved one have been injured by the HVAD pump or controller by Heartware Inc. contact one of our experienced product liability attorneys today for a free and confidential consultation.