Recall Class: Class I
Date Recall Initiated: Dec. 6, 2013
Product: HeartWare Ventricular Assist System
Reason for Recall:
The company 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.
Company Press Release:
HeartWare International, Inc. today announced issuance of a clinician and patient reminder concerning the Urgent Medical Device Correction distributed to all of its clinical sites by the company in December 2013. The device correction discussed eight complaints that the locking mechanism of the driveline connector of the HeartWare Ventricular Assist System had failed to engage and instructed clinicians to inspect patient driveline connectors. To ensure full awareness, the company is in the process of redistributing this information to clinicians and patients.
Impacted HeartWare Systems carry catalog numbers: 1100, 1101, 1102, 1103, 1104, and 1205 with serial numbers ranging from: HW001 to HW11270 and HW20001 to HW20296. All devices manufactured since November 2013 incorporate changes in manufacturing procedures which address this issue.
A disconnected driveline would result in a temporary pump stop which could cause serious injury or death, depending on the function of a patient’s native heart. HeartWare issued the December 2013 correction following eight reported events in which the locking mechanism failed to engage. Four of these eight cases resulted in a temporary pump stop; however, none resulted in patient injury.
Patients are requested to discuss the correction notice with their physician or VAD Coordinator. Clinicians are asked to inspect the patient’s driveline connector for proper locking at implant and at each routine clinic visit to ensure that the connector assembly remains secure. Should the locking mechanism fail to engage or the driveline disconnects from the controller, the driveline connector should be pushed back into the controller immediately. Clinicians should promptly call their HeartWare representative to arrange a permanent repair.
For more information, visit the Food and Drug Administration (FDA).