FDA-Device2019-08-28Class II
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Thoratec Corp.
Hazard
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.
Sold states
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.
Affected count
7200 left ventricular assist systems
Manufactured in
6035 Stoneridge Dr, N/A, Pleasanton, CA, United States
Products
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2019Don't want to check this manually?
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