MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software
AUDIENCE: Cardiology, Risk Manager, Transplantation, Nursing, Patient
ISSUE: Medtronic Mechanical Circulatory Support is expanding this recall to include an additional product code and instructions to exchange recalled products.
The company recalled 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.
Since the issuance of the November 2016 recall, Medtronic Mechanical Circulatory Support has developed an updated HVAD controller and power management software to address the power connector issues.
BACKGROUND: The HeartWare Ventricular Assist Device (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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at: