Recall Z-2263-2020— Endologix, Inc.
Class I · Terminated
Class I FDA medical device recall by Endologix, Inc., initiated 2020-05-06, terminated 2024-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J. Reason: 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..
- Recalling firm
- Endologix, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-05-06
- Terminated
- 2024-05-03
- Firm location
- Santa Rosa, CA, United States
Product description
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.