Z-2349-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- March 30, 2019
- Termination Date
- August 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 outflow graft units
Product Description
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
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.
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.
Code Information
105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 50000000 and higher. UDI/GMDN 00813024013266 / 61747