AUDIENCE: Risk Manager, Cardiology, Transplantation
ISSUE: HeartWare, Inc. received reports where the driveline connector locking mechanism 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.
BACKGROUND: 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. Also known as HeartWare Ventricular Assist Device (HVAD), the system is designed for in-hospital and out-of-hospital settings, including transportation by fix-wing aircraft or helicopter.
Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205.
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.
RECOMMENDATION: Health professionals should 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, inspect the patient’s driveline connector for proper locking and to ensure that the connector assembly remains secure. During the inspection, 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, push the connector back into the controller and immediately contact a HeartWare Clinical Engineer to perform a permanent field repair.
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/29/2014 - Recall Notice - FDA]