Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
Class I - DangerousWhat Should You Do?
- Check if you have this product: The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package. Model Number: TV-AB2980-D Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34 Expiry dates ranging "May-17" through "Jun-17"
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Trivascular, Inc
- Reason for Recall:
- TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
Product Codes/Lot Numbers:
The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package. Model Number: TV-AB2980-D Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34 Expiry dates ranging "May-17" through "Jun-17"
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0125-2015
Related Recalls
Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in