Thoratec Corp.: Medical Device Recall in 2019 - (Recall #: Z-2348-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

Product Classification:

Class II

Date Initiated: March 30, 2019

Date Posted: August 28, 2019

Recall Number: Z-2348-2019

Event ID: 83357

Reason for Recall:

Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

Status: Terminated

Product Quantity: 7200 left ventricular assist systems

Code Information:

106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or higher. UDI/GMDN 00813024013297 / 47533

Distribution Pattern:

Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated