Recall Z-1301-2024— Thoratec Corp.

Class I FDA medical device recall by Thoratec Corp., initiated 2024-02-19. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.. Reason: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System..

Recalling firm

Thoratec Corp.

Classification

Class I

Status

Ongoing

Initiated

2024-02-19

Firm location

Pleasanton, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.