Z-2348-2019 Class II Terminated
FDA device recall Z-2348-2019 was initiated by Thoratec Corp. on March 30, 2019 and is designated Class II. 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… The recall status is terminated (terminated August 24, 2020). Affected quantity: 7200 left ventricular assist systems.
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
- 7200 left ventricular assist systems
Product Description
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
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
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