News | Ventricular Assist Devices (VAD) | August 05, 2015

HeartWare Expands Recall of Ventricular Assist System

Company expanded alerts in mid-June to address issues with alignment guides, battery failure and driveline connectors

HeartWare, ventricular assist device, HeartWare VAD, recall, update

August 5, 2015 — HeartWare expanded the Class I recall of its ventricular assist device in mid-June due to concerns over damaged or failing device components. The three mid-June recalls are part of a series of five alerts related to the HeartWare VAD dating back to April.

The HeartWare VAD 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.

On June 16, the company issued an alert related to damaged alignment guides and connector pins. According to the agency, the alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to the system. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. The company has reported 33 instances of malfunction and one serious injury related to this problem.

On June 19, alerts were issued related to battery failure and damaged driveline connectors. According to the alert, the battery that powers an alarm in the controller may fail over time. If the battery fails, the alarm will not alert the patient in the event that both external power sources for the HVAD are disconnected.

Regarding the driveline connector, damage to the component may occur if the driveline is pulled too often with too much force. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death.

The firm has received a total of three reports, including one serious injury and two reports of death, related to damage to this issue. HeartWare said it would replace all defective controllers by the end of June 2016.

For more information: www.fda.gov

Related Content

Cardiac Dimensions Randomizes First Patient in CARILLON Trial of Mitral Contour System
News | Heart Failure | September 20, 2018
Cardiac Dimensions announced the company has randomized its first patient in the CARILLON Pivotal Trial.
Antithrombin Drug Ineffective in Heart Failure With Sinus Rhythm and Coronary Disease
News | Heart Failure | September 07, 2018
The antithrombin drug rivaroxaban does not reduce the risk of a composite endpoint of survival, myocardial infarction...
Tafamidis Improves Survival in Rare Heart Condition
News | Heart Failure | September 06, 2018
Tafamidis is the first treatment to improve survival and reduce hospitalizations in a rare heart condition called...
New Target for Treating Heart Failure Identified by Penn Medicine Researchers

Microtubules in heart cells from a healthy patient (left) and from a patient with heart failure. The dense network of detyrosinated microtubules impedes the motion of the failing heart cell during the heart beat. Credit: Ben Prosser lab, Perelman School of Medicine, University of Pennsylvania

News | Heart Failure | June 25, 2018
New research finds changes in cellular struts called microtubules (MT) can affect the stiffness of diseased human heart...
Gencaro Does Not Reduce Atrial Fibrillation Risk in Heart Failure Patients
News | Heart Failure | May 30, 2018
Data from the GENETIC-AF trial was presented in a “Late Breaking Clinical Trials” oral presentation at the European...
Cardiac Contractility Modulation Safe and Effective as Heart Failure Treatment

Image courtesy of Impulse Dynamics

News | Heart Failure | May 18, 2018
In a new study, cardiac contractility modulation (CCM) therapy was confirmed to significantly improve exercise...
V-Wave Closes $70M Financing to Support Pivotal Study of Heart Failure Therapy
News | Heart Failure | May 16, 2018
Israel-based V-Wave Ltd. recently closed a $70 million Series C financing for its proprietary, minimally invasive...
News | Heart Failure | May 14, 2018
Ancora Heart Inc. announced the expansion of the company’s U.S. feasibility study to evaluate the investigational...
Protein Clumping May Contribute to Heart Failure Development

A PET scan detects clumping proteins in rat hearts (top). The enlarged heart (right) is one with heart failure. Other PET scans showing blood flow in the rat hearts (bottom) show that the protein clumps aren't due to circulation problems. Image courtesy of Circulation Research, May 11, 2018.

News | Heart Failure | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
Overlay Init