Recall Z-2349-2019— Thoratec Corp.
Class II · Terminated
Class II FDA medical device recall by Thoratec Corp., initiated 2019-03-30, terminated 2020-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Thoratec Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-30
- Terminated
- 2020-08-24
- Firm location
- Pleasanton, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.