Patient Errors On Expiring Batteries Spurs Second Thoratec HeartMate II Recall
This article was originally published in The Gray Sheet
Executive Summary
Thoratec issued an Urgent Medical Device Correction Letter Sept. 14 to all hospitals with patients implanted with HeartMate II Left Ventricular Assist Systems and pocket controllers, following the death of two patients, and one serious injury when patients failed to follow instructions on expiring batteries. It follows a 2014 recall tied to patients' switch to the pocket controllers.
You may also be interested in...
Thoratec Warns Of Potentially Lethal Complications When Patients Switch To New HeartMate II Controller
Serious adverse events have been linked to patients struggling to switch their Thoratec HeartMate II left-ventricular assist devices from an older controller system to the newer Pocket Controller system. The company is updating the labeling and training materials for the system and warning doctors and patients to communicate to ensure they understand how to convert to the Pocket Controller.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.