Reported Jun 17, 2020 · Terminated
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I,…
Endologix, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Endologix, Inc. · 3910 Brickway Blvd · Santa Rosa, CA · 95403-1070
Is this the product you have?
- Ovation iX Abdominal Stent Graft Systems
- REF
TV-AB2080-ITV-AB2080-JTV-AB2380-ITV-AB2380-JTV-AB2680-ITV-AB2680-JTV-AB2980-ITV-AB2980-JTV-AB3480-ITV-AB3480-J
- Lot codes and dates
- All Lot and Serial Numbers not yet implanted
- Amount recalled
- 9156
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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