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All product recalls associated with Endologix, Inc..
Total Recalls
5
Past Year
0
Class I (Serious)
0
Most Recent
May 2020
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health c
This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health
Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
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.