IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current us
Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System
IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current us