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Recall Observatory FDA recall evidence

Device product

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

Z-2348-2019

March 30, 2019

Class II

Product summary

Firm
Thoratec Corp.
Event
Event 83357
Status
Terminated
Classification
Class II
Quantity
7200 left ventricular assist systems
Official record key
device-enforcement:Z-2348-2019

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.