Recall Z-2349-2019 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp.
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
| Date | Mar 30, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| Action | On March 30, 2019 all consignees were hand delivered the "Urgent Medical Device Recall" letter. The recall letter stated the following: 1. Abbott is recalling 208 HeartMate 3 Outflow Graft units globally (87 within the US). An Abbott Representative will be contacting you within the coming weeks to identify the specific units that are impacted in your inventory and replace them. 2. In the interim, continued implants with the current HeartMate 3 Outflow Grafts can still be conducted with standard implant procedures by following the HeartMate 3 Instructions for Use. However, in addition to foll |
| Quantity | 149 outflow graft units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.