FDAFDA · Food and drugs·Recall number Z-2349-2019
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
Published August 28, 2019 · Recall initiated: March 30, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Thoratec Corp.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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