U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The tip may separate from the catheter sheath inner core during insertion of the graft. the delivery catheter is being recalled. the implanted devices are not affected.
조치
The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05.
Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.